Clinical trial NCT05844137
Conditions: NAFLD Diabetes Mellitus
Sponsor: Duke University
Start date: 2023-09-18; Completion date: 2024-01-29
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 diabetes (T2D) in Duke University Healthcare system (DUHS). We will enroll 10-15 Latinx and 10-15 Black patients with T2D and NAFLD, based on having mildly elevated liver enzymes (ALT \>/= 40 IU/mL in males, ALT \>/= 31 IU/mL in females) and exclusion of other liver diseases (e.g., viral hepatitis, alcohol abuse).

Intervention content will include: 1) NAFLD education; 2)diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care.

Intervention feasibility will be evaluated by examining recruitment rates, retention rates, and study visit completion rates. Acceptability will be assessed by survey and through qualitative interviews. The project objectives and intervention are minimal risk. The expected risks will not exceed those of usual care.

Detailed description:

Arms: arm 1: Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care
Interventions: intervention 1: NAFLD Education intervention 2: diet/lifestyle support intervention 3: T2D medication management intervention 4: clinically-indicated liver testing and care
Intervention descriptions: intervention 1: NAFLD Education intervention 2: diet/lifestyle support intervention 3: T2D medication management intervention 4: clinically-indicated liver testing and care

Protocol documents:
ICF_000.pdf: 
 
 
 
 
Improving Detection and Evidence-based Care of NAFLD in Latinx and Black 
Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study 
 
 
 
NCT05844137 
 
 
 
Approval Date: 05/18/2023 
 
 
 
Anastasia-Stefania Alexopoulos, MD 
Study Principal Investigator 
Duke University  
 


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Docrs Econsent Template Instrument
Please complete the survey below.
Thank you!
CONCISE SUMMARY
NAFLD-DM is a program that is designed to promote detection and evidence-based management of
nonalcoholic fatty liver disease (NAFLD) in people with type 2 diabetes. The purpose of this study
is to determine whether NAFLD-DM is acceptable to participants, and whether it will be feasible to
implement into our healthcare system. NAFLD-DM will be piloted in people who identify as either:
Latino/Latina/Hispanic ethnicity and/or Black or African American race - the reason we are
focusing on these groups is because we want to make sure that NAFLD-DM is designed to benefit
individuals who are at highest risk of having bad outcomes related to NAFLD.
In this 3-month research study, all eligible participants will go through the NAFLD-DM program.
This will include:
-Surveys to learn more about you and your medical history at the beginning and end of the study
-Blood tests to check hemoglobin HbA1c and liver tests at the beginning and end of the study
-Education about NAFLD and its risks
-Diet and lifestyle support to help with both diabetes and NAFLD
-Potential changes to diabetes medications to promote liver health
-If indicated, ordering of additional blood tests or imaging studies related to the liver
Risks of partaking in this study include: abnormal blood sugars, side effects to diabetes medications,
blood sampling risks, loss of confidentiality.
You are being asked to take part in this research study because you have type 2 diabetes, and likely
NAFLD based on abnormal liver tests. Research studies are voluntary and include only people who
choose to take part. Please read this consent form carefully and take your time making your decision.
As your study doctor or study staff discusses this consent form with you, please ask him/her to explain
any words or information that you do not clearly understand. We encourage you to talk with your
family and friends before you decide to take part in this research study. The nature of the study, risks,
inconveniences, discomforts, and other important information about the study are listed below.
Please tell the study doctor or study staff if you are taking part in another research study.
Dr. Anastasia-Stefania Alexopoulos, MBBS will conduct the study and it is funded by Duke CTSA
KL2 grant, which is in turn from the National Institutes of Health (NIH). This grant will pay Duke
University to perform this research, and these funds may reimburse part of Dr. Alexopoulos's salary
WHO WILL BE MY DOCTOR ON THIS STUDY?
If you decide to participate, Dr. Alexopoulos will be your doctor for the study. She will be in contact
with your regular health care provider throughout the time that you are in the study and afterwards, if
needed.
WHY IS THIS STUDY BEING DONE?
The purpose of this study is to understand whether NAFLD-DM is acceptable to people with diabetes
and NAFLD, and to determine if/how to refine NAFLD-DM so we can expand it and eventually
integrate it into the healthcare system. In this study, we are focusing on individuals who identify
themselves as Latino/Latina/Hispanic ethnicity and/or Black or African American race. These
individuals are at highest risk of bad outcomes related to NAFLD, and we want to make sure that
NAFLD-DM is designed in a way that will help these groups.


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HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
Approximately 20-30 people will take part in this study at Duke.
WHAT IS INVOLVED IN THE STUDY?
Procedures related to the study:
1. If you agree to be in this study, you will be asked to sign and date this consent form.
2. We will ask you questions and review your medical records for information about you (age, race,
etc.) and your health (medical history, lab values, etc.).
3. Although this study involves few risks beyond those that are part of routine diabetes care, the
changes your body goes through during pregnancy may affect your diabetes treatment plan.
Diabetes and liver disease in pregnancy are both associated with an increased risk of
complications for mothers and babies, and women with these conditions are advised not to
become pregnant without first talking to a specialist in high-risk pregnancy. If you are are
currently pregnant or planning a pregnancy, you cannot participate in this study. If you do
become pregnant during the study, we will continue with NAFLD-DM except for adding new
medications. We will stop diabetes medications that are not indicated in pregnancy and reach out
to your diabetes provider and a specialist in high-risk pregnancy to transition your medication
management back to them.
4. The study will last approximately 3 months, and will include at least 6 virtual visits (including
the enrollment visit to determine eligibility). Visits will occur at varying intervals over the
course of the 3 months. See Table 1 for a summary of NAFLD-DM study visits.
a. Enrollment visit: This visit should take somewhere between 40 and 60 minutes. We will ask
you to review and sign the online consent form for study participation. We will ask you to
complete a series of questionnaires, which can be done remotely online or over the phone
with study staff. We will work with you to plan when and where to complete your blood tests
(for hemoglobin A1c, and liver tests) if needed. Approximately one tablespoon of blood will
be collected, if you have not already done these within 3 months prior to enrollment.
Participants will receive $50 for completing the enrollment visit including questionnaires and
necessary blood tests.
b. NAFLD-DM. Once your enrollment visit is complete, you will start NAFLD-DM. This will
include:
- NAFLD education: You will have a virtual/remote visit scheduled with Dr.
Alexopoulos or another study member who will provide you with information about
NAFLD, and to answer your questions.
- Diet/lifestyle support: You will have three diet/lifestyle visits scheduled once per
month for three months. Each of the three sessions will last approximately 30
minutes. During the sessions we will provide you with information about
diet/lifestyle habits that will promote health of your liver. We will also review your
diet/lifestyle patterns and promote goal setting together.
- Medication management: We will schedule a virtual visit with you and Dr. Alexopoulos to discuss and possibly
adjust your diabetes medications. These sessions occur on an as needed basis each month and could last
approximately 20 minutes each. You will be responsible for costs and copays of new medications that are started - if
the cost is too high, you can let the study team know and it will be discontinued. The first medication management
visit will be at baseline, soon after enrollment. During these visits, Dr. Alexopoulos will review your blood sugar
values with you, and you will both decide on medication changes that may benefit NAFLD based on your medical
history. If you need a new glucometer and/or supplies, Dr. Alexopoulos can prescribe this for you as part of the study,
however you will be responsible for costs of these supplies. 
Your primary care doctor or Endocrinologist will be alerted to changes through the
Duke electronic health record, and once this 3-month study is over, you will continue
to follow with your previous providers for your diabetes management.
- Clinically indicated liver tests/referrals: Dr. Alexopoulos will review your records to
see whether any additional tests or referrals are needed for your liver - this will occur
as part of medication management visits. As indicted in Table 1, frequency and
timing of medication management and ordering of tests/referrals will vary by
participant (and depending on medication adjustments made), but may occur monthly
for the duration of the study (at 0,1,2,3 months). 


c. At the end of the study (3 months), you will get repeat blood tests (hemoglobin A1c and liver
tests) and we will work with you to arrange a time to complete final questionnaires and your
interview. Virtual interviews will be audio recorded, and will be approximately 30 minutes in
length. Participants will receive $50 after end-of-study questionnaires and interviews have
been completed.
5. We will use your contact information to share study results with you.
6. Participating in this study is voluntary, and your refusal to participate will involve no penalty or
loss of benefits to which you are otherwise entitled. If you do not sign this consent form, you will
continue to receive care from your primary doctors, but not as part of this study.
7. You will continue to receive care for your diabetes, NAFLD and other conditions with your
current providers throughout the study period. Your current Primary Care or Endocrinology will
be updated about any changes made to your medications by the study team.
[Attachment: "Table 1 _consent.png"]
HOW LONG WILL I BE IN THIS STUDY?
The study will be approximately 3 months long. You can choose to stop participating at any time
without penalty or loss of any benefits to which you are entitled. However, if you decide to stop
participating in the study, we encourage you to talk with the study staff first.
Clinically relevant results of this research will be communicated with you after the study has been
completed, and it will include aggregated data showing how acceptable NAFLD-DM was to participants
(using a survey measure) and how feasible it was to conduct the study.
WHAT ARE THE RISKS OF THE STUDY?
- We expect that the physical risks and discomforts of this study will not be any different than usual
care of diabetes and NAFLD. A risk of any diabetes medication is causing a low blood sugar.
o Symptoms of a low blood sugar can include sweating, confusion, and nausea, and rarely a
loss of consciousness or seizure.
- You will receive blood test to check your HbA1c and liver tests up to two times during this study.
Risks associated with blood draw include a momentary discomfort and/or bruising. Infection, excess
bleeding, clotting or fainting are also possible, although unlikely.
- We will be collecting private health information from you during this study, which will be kept
confidential. We will assign random study codes to participants to protect confidentiality, and this
will allow information to be stored and analyzed on secure Duke servers without personal identifiers.
There is still, however, the potential risk of loss of confidentiality. Every effort will be made to keep
your information confidential; however, this cannot be guaranteed.
- Some patients may experience discomfort from being asked questions about their well-being as it
relates to their diabetes and overall health. You may refuse to answer any of the questions and you
may take a break at any time during the study. Study staff will be sensitive when asking questions
and will allow you to recover before proceeding with further questions.
- Some questions we ask during the survey may be considered sensitive to some people; if you do not
wish to answer any question, we can proceed to the next question upon your request.
- All surveys are completed using encrypted software and are kept confidential.
- If you experience discomfort that you think may be related to the research, you can call the study
team.
There may be risks, discomforts, drug interactions or side effects with study participation that are not yet
known.


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ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
If you agree to take part in this study, your diabetes and liver health may improve; however, this cannot
be guaranteed. We hope that in the future the information learned from this study will also benefit other
people with your conditions.
WILL MY INFORMATION BE KEPT CONFIDENTIAL?
Participation in research involves some loss of privacy. We will do our best to make sure that
information about you is kept confidential, but we cannot guarantee total confidentiality. Your personal
information may be viewed by individuals involved in this research and may be seen by people
including those collaborating, funding, and regulating the study. We will share only the minimum
necessary information in order to conduct the research. Your personal information may also be given out
if required by law.
As part of this study, you will be asked to have certain lab and imaging tests performed. These tests
would have been done as part of your regular care. The study doctor will use these test results both to
treat you and to complete this research. These test results will be recorded in your medical record and
will be reported to your primary care team, and the NAFLD-DM study team.
As part of the study, results of your study-related laboratory tests, and procedures may be reported to
Duke and its affiliates. In addition, your records may be reviewed in order to meet federal or state
regulations. Reviewers may include representatives and affiliates of the Duke University Health System
Institutional Review Board, and others as appropriate. If any of these groups review your research
record, they may also need to review your entire medical record. At the end of the study, you will be
asked to conduct a 30-minute (virtual) interview that will be audio recorded. The recordings will be
saved in a secure Duke folder behind the Duke Firewall. Audio recordings will not be transcribed, and
they will be deleted from the Duke folder 3 years after the study concludes.
The study results will be retained in your research record for at least six years after the study is
completed. At that time either the research information not already in your medical record may be
destroyed or information identifying you will be removed from such study results at DUHS. Any
research information in your medical record will be kept indefinitely. While the information and data
resulting from this study may be presented at scientific meetings or published in a scientific journal,
your name or other personal information will not be revealed. While the information and data resulting
 from this study may be presented at scientific meetings or published in a scientific journal, your name or other
personal information will not be revealed.
Some people or groups who receive your health information might not have to follow the same privacy
rules. Once your information is shared outside of DUHS, we cannot guarantee that it will remain private.
If you decide to share private information with anyone not involved in the study, the federal law
designed to protect your health information privacy may no longer apply to the information you have
shared. Other laws may or may not protect sharing of private health information.
WHAT ARE THE COSTS TO YOU?
You or your insurance provider will be responsible and billed for all costs related to your routine
medical care, including copayments and deductibles. Routine medical care services are those that you
would have received for your condition if you were not participating in this research study. Not all
services are covered by insurance. Some procedures or scans may require pre-authorization by your
insurance plan. We will notify you if we learn that a service is not covered by your insurance plan as
part of the pre-authorization process. If it is not covered, you will be responsible for paying for it. The
amount of your out-of-pocket expense will depend on your insurance plan. For beneficiaries with
Medicare Advantage Plans, traditional Medicare is billed for the routine cost of a research study. You
may have more or higher co-pays than with a Medicare Advantage plan. Please discuss the costs of the
study with Dr. Anastasia-Stefania Alexopoulos. At your request, a Financial Counselor in the clinic
may provide you with an estimate of costs for routine services.


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WHAT ABOUT COMPENSATION?
You will be compensated up to $100 for completing all visits as part of this study. After completing the
baseline assessment, you will receive $50.You will also be compensated $50 for completing the end-of
study assessment (which includes surveys and the interview).
WHAT ABOUT RESEARCH RELATED INJURIES?
Immediate necessary medical care is available at Duke University Medical Center in the event that you
are injured as a result of your participation in this research study. However, there is no commitment by
Duke University, Duke University Health System, Inc., or your Duke physicians to provide monetary
compensation or free medical care to you in the event of a study-related injury.
For questions about the study or research-related injury, contact Dr. Anastasia-Stefania Alexopoulos at
919-684-8111, or request page to 970-1154 during regular business hours, after hours, or on weekends
and holidays.
WHAT ABOUT MY RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM THE STUDY?
You may choose not to be in the study, or, if you agree to be in the study, you may withdraw from the
study at any time. If you withdraw from the study, no new data about you will be collected for study
purposes unless the data concern an adverse event (a bad effect) related to the study. If such an adverse
event occurs, we may need to review your entire medical record.
Your decision not to participate or to withdraw from the study will not involve any penalty or loss of
benefits to which you are entitled, and will not affect your access to health care at Duke, and will not
affect your job status if you are a Duke employee. If you do decide to withdraw, we ask that you email
Dr. Alexopoulos at asa61@duke.edu.
We will tell you about new information that may affect your health, welfare, or willingness to stay in
this study.
Your doctor may decide to take you off this study if your condition gets worse, if you have serious side
effects, or if your study doctor determines that it is no longer in your best interest to continue. The
sponsor or regulatory agencies may stop this study at anytime without your consent. If this occurs, you
will be notified and your study doctor will discuss other options with you.
Your data may be stored and shared for future research without additional informed consent if
identifiable private information, such as your name and medical record number, are removed. If your
identifying information is removed from your data, we will no longer be able to identify and destroy
them. The use of your data may result in commercial profit. You will not be compensated for the use of
your data other than what is described in this consent form.
A description of this clinical trial will be available on https://clinicaltrials.gov/ as required by U.S. Law.
This Web site will not include information that can identify you. At most, the Web site will include a
summary of the results. You can search this Web site at any time.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or a research-related injury, or if you have problems, concerns, questions
or suggestions about the research, contact:
- Dr. Anastasia-Stefania Alexopoulos at 919-684-8111 (request page to 970-1154) during
regular business hours, after hours, or on weekends and holidays.
- Susanne Danus, Clinical Research Coordinator, at 919-681-4453 during regular business
hours.
For questions about your rights as a research participant, or to discuss problems, concerns or suggestions
related to the research, or to obtain information or offer input about the research, contact the Duke
University Health System Institutional Review Board (IRB) Office at (919) 668-5111.


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STATEMENT OF CONSENT
"The purpose of this study, procedures to be followed, risks and benefits have been explained to me. I
have been allowed to ask questions, and my questions have been answered to my satisfaction. I have
been told whom to contact if I have questions, to discuss problems, concerns, or suggestions related to
the research, or to obtain information or offer input about the research. I have read this consent form and
agree to be in this study, with the understanding that I may withdraw at any time. I have been told that I
will be given a signed and dated copy of this consent form."
Please select one:
I have read the consent document and I wish to participate in the study.
I have read the consent document and I DO NOT wish to participate in the study.
Participant First Name
__________________________________
Participant Last Name
__________________________________
Participant's E-mail Address
__________________________________
Participant Signature
__________________________________________
Date
__________________________________
Protocol Number
__________________________________
Consent Version Date
__________________________________
Consent Expiration Date
__________________________________
Please feel free to download a copy of the consent form for further review.
[Attachment: "NAFLD_DM_ICF_Approved 2023.04.18.pdf"]
Pro00113239
05/18/2023
05/18/2025

SAP_002.pdf: 
 
 
Official Title:  Improving Detection and Evidence-based Care of NAFLD in Latinx 
and Black Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study     
 
NCT:  NCT05844137 
 
IRB Document Date:  5/31/2024 


Statistical Design and Power 
V: May 31,2024 
 
We expect to enroll 15 participants who self-identify as Black of African American (AA), and 15 
participants who self-identify as Hispanic/Latinx. 
 
Our quantitative primary outcomes will be feasibility and acceptability, as below: 
 
Feasibility of 
system-level NAFLD 
detection approach 
 
Patients who met criteria for NAFLD after chart review / total 
number of potentially-eligible patients based on our EHR criteria. 
We will deem this approach feasible if detection rates are >70%. 
Feasibility of patient-
level management  
We will assess recruitment rates, retention rates and study visit 
completion rates. We will consider our management approach to 
be feasible if we can recruit at least 10 Black/AA patients and 10 
Hispanic/Latinx patients over 12 weeks (3 months) 
Acceptability of 
intervention by 
participants 
We will calculate the mean and standard deviation of the 
Treatment Acceptability and Preferences (TAP) measure at 3 
months; a score >3 will be deemed acceptable.  
 
Secondary outcomes: Patient-level outcomes will be examined at 12 weeks (3 months), and 
these include: hemoglobin A1c, alanine aminotransferase level (ALT), and survey measures 
(i.e., self-efficacy, perceived autonomy support and quality of life). Effect size of the pre-post 
difference and 95% confidence intervals will be calculated.  
 
This pilot study will not have enough statistical power to establish effectiveness of the 
intervention for these secondary outcomes. Results of an intervention to improve NAFLD 
detection and management in Black and/or Hispanic/Latinx persons with T2D has not been 
previously reported. Therefore, the primary goal of this pilot study is to generate evidence in this 
area to estimate effect sizes and show feasibility of the intervention to guide future work. 

Prot_001.pdf: 
 
 
Official Title:  Improving Detection and Evidence-based Care of NAFLD in Latinx 
and Black Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study     
 
NCT:  NCT05844137 
 
IRB Document Date:  5/31/2024 


Improving detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 
diabetes (NAFLD-DM): A pilot study  
PI: Anastasia-Stefania Alexopoulos, MD 
 
Page 1 of 7 
Version 2: May 31, 2024 
 
Background: NAFLD is a critically overlooked T2D complication, and T2D accelerates NAFLD progression to 
poor outcomes, such as cirrhosis, liver cancer and death.1, 2 As with other T2D complications, racial and 
ethnic disparities exist in detection and care of NAFLD, although the drivers of these disparities are poorly 
understood, especially in the context of T2D care.3 Based on my prior work published in Hepatology,4 there are 
racial/ethnic disparities in who receives liver biopsy to diagnose NAFLD. For instance, of the 350 patients with 
T2D who underwent liver biopsy for NAFLD between 2007-2019 in DUHS, only 1.7% and 13% of patients were 
Latinx and Black, respectively.4 This is striking when considering that these underrepresented minority groups 
are disproportionately impacted by T2D complications and poor liver outcomes due to NAFLD.3 Because T2D 
imparts higher risk of poor liver outcomes due to NAFLD,1, 2 and because underrepresented minority 
groups are likewise at higher risk of these outcomes, Latinx and Black patients with T2D should be 
prioritized for proactive detection and intensive management of NAFLD.5, 6  
 
Diabetes care guidelines specifically call for further evaluation of NAFLD in T2D in the presence of 
abnormal liver enzymes, or when imaging has revealed hepatic steatosis.6 Detection of high-risk forms of 
NAFLD is critical in T2D, not only because of the elevated risk of poor NAFLD outcomes in T2D, but also 
because we can use T2D approaches to effectively treat NAFLD.5, 7, 8 In a recently published study,9 we 
showed that T2D medications that prevent NAFLD progression are vastly underutilized in high-risk patients 
with T2D. Currently, disparities in the detection and treatment of NAFLD in patients with T2D are poorly 
characterized; however, given known racial and ethnic disparities in biopsy rates and NAFLD 
outcomes, we urgently need to understand disparities in NAFLD detection and care in T2D. Such data 
could directly inform the development of interventions to foster the equitable management of T2D and 
NAFLD. To address these critical issues, I propose a KL2 program of research that will characterize health 
disparities in NAFLD detection and care in T2D, and then develop and pilot a culturally-competent 
 intervention that will improve recognition and management of Latinx and Black patients with T2D and NAFLD.  
 
Significance: NAFLD-related liver disease and mortality are high – based on 2015 data, 16.5 million 
Americans have NASH (i.e., high-risk NAFLD) and mortality in patients with NAFLD is up to 1.27 million 
annually.10 These rates are projected to increase by over 130% in the next 10 years.10 This increased clinical 
burden will result in direct medical and societal costs of over $300 billion/year.11, 12 Efforts to prevent this rise in 
NAFLD complications and costs should focus on populations at highest risk for poor outcomes; thus, this 
proposal’s focus on T2D and high-risk racial/ethnic groups is highly significant. Furthermore, given known 
health disparities in NAFLD detection, and in T2D care in general, our emphasis on addressing disparities is 
crucial. This proposal will generate a patient-facing intervention that will improve evidence-based care of 
NAFLD in T2D, with a focus on reaching Latinx and Black patients who are disproportionately impacted by T2D 
complications,13 especially NAFLD.3 This work is critically urgent as the U.S. burden of NAFLD is rising, and 
several drugs for NAFLD in T2D will come to market soon; this proposal will support equitable use of current 
and emerging therapies for NAFLD, assuring that those with the greatest need are able to access effective 
treatment. Because current services are already struggling to reach rising numbers of patients with NAFLD, a 
major strength of this proposal is its support of multidisciplinary efforts to tackle this public health threat.  
 
Innovation: This proposal is novel in multiple ways. First, the drivers underlying health disparities in NAFLD 
detection are poorly understood, and this proposal will address this gap. Second, there are no existing 
interventions to promote detection and management of NAFLD as part of T2D care, and certainly none to 
address disparities in these areas. Third, I am proposing an innovative intervention development approach that 
will leverage community engagement resources at Duke and maximize intervention relevance and feasibility 
through use of stakeholder input. No studies have queried minority communities to understand how best to 
design/deliver an intervention to improve outcomes in NAFLD and T2D. Notably, this proposal will proactively 
improve the care of an exceedingly high-risk, high-cost group through a joint T2D/NAFLD intervention. To our 
knowledge, this will be the first intervention geared towards intensively co-managing these linked conditions.  
 
Research Strategy/Approach 
This project will assess the feasibility and acceptability of an intervention for improved detection and 
evidence-based care of NAFLD in Latinx and Black patients with T2D.  
 


Improving detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 
diabetes (NAFLD-DM): A pilot study  
PI: Anastasia-Stefania Alexopoulos, MD 
 
Page 2 of 7 
Version 2: May 31, 2024 
 
Rationale: Below is a conceptual framework that has guided the design, and will inform the execution, of our 
intervention. This framework includes features of the Health Belief Model (HBM)14 to highlight patient-level 
strategies for disease prevention, and the Chronic Care Model (CCM)15 to highlight the system-level 
components aimed at improving the care of NAFLD. As depicted in the Figure below, this intervention 
represents an innovative approach to redesigning care and using available EHR to promote equitable 
detection of NAFLD (right side of figure). Once detected, we will engage patients with NAFLD and T2D in 
strategies to promote their overall health and halt, or even reverse their NAFLD. These patient-level 
approaches will consider how to alter patient perceptions (i.e., perceived threat of NAFLD, perceived 
benefits & barriers) and understand patient cues to action, to promote patient engagement with the care 
plan (left side of Figure). The ultimate objective of this project is to lead to productive interactions between 
patients and the care teams (center of Figure) that will ultimately lead to better detection and care of NAFLD in 
those at highest risk. Prior work has helped us develop this intervention in a culturally-appropriate manner to 
allow us to reach high-risk racial/ethnic groups with T2D and NAFLD. This will be a feasibility pilot.  
 
 
Figure: Conceptual framework guiding intervention design and execution 
 
 
 


Improving detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 
diabetes (NAFLD-DM): A pilot study  
PI: Anastasia-Stefania Alexopoulos, MD 
 
Page 3 of 7 
Version 2: May 31, 2024 
 
Intervention content and design: The first intervention component will involve proactive detection of NAFLD in 
Latinx/Black patients with T2D using DEDUCE; this EHR-based approach will allow us to identify eligible study 
participants in DUHS based on our inclusion/exclusion criteria listed below. The next intervention component 
will focus on delivery of evidence-based care, which will rely on a proactive care team that is knowledgeable 
about NAFLD and can intervene, as well as an informed and activated patient who wants to engage with care.  
Once identified, patients will receive the following guideline-concordant content as part of the intervention: 
a) diet/lifestyle support, with counseling on hypocaloric diet and moderate-intensity exercise;5 b) NAFLD 
education;5 c) medication management, with proactive use of T2D medications known to be protective against 
NAFLD progression (pioglitazone, GLP-1RA, SGLT2i);5, 7, 16 and d) clinically-indicated liver testing and care 
based on guidelines.5 The content of this intervention will be delivered remotely via telehealth approaches.  In 
order to ensure feasibility within the proposed KL2 timeline, we have limited the pilot duration to 3 months. This 
will allow time to observe change in liver enzymes, as well as HbA1c. Table 1  
shows when intervention content will be delivered throughout the  
 
Study population: We will enroll 10-15 Latinx/Hispanic and 10-15 Black patients with T2D and NAFLD, based 
on elevated ALT and exclusion of other liver diseases (e.g., viral hepatitis, alcohol abuse).  
 
Research activity:  
Detection of NAFLD in T2D: The Duke DEDUCE tool will be used to generate a report of potentially eligible 
Latinx and Black patients with an ICD code for T2D (E11.xx) and at least one ALT >40 IU/mL in males or > 31 
IU/mL in females17 in the preceding 12 months. For this feasibility pilot, we will also restrict eligibility to patients 
who have a PCP or Endocrinologist in DUHS to facilitate communication regarding T2D medication changes 
during the study period. We anticipate >2,000 patient will meet our inclusion and exclusion criteria. A report will 
be exported from DEDUCE and I will review the charts of potentially eligible patients to exclude individuals with 
liver dysfunction likely due to an etiology other than NAFLD. We will not exclude patients with an ICD-10 code 
for NASH (K75.81), as long as they are not medically optimized (i.e. on pioglitazone and GLP-1RA), since 
these individuals serve to benefit from the intervention.  
The first 50 patients who meet eligibility will be mailed a letter or sent a MyChart message with opt-out 
instructions. Patients who do not opt out will be contacted by phone and, if interested, they will sign an e-
consent form via REDCap. In parallel 
to the above recruitment approach, we 
will also advertise this study in the 
community with the help of community 
partners that had assisted us in the 
design of the intervention, i.e., Latin-19 
group and the AME Zion partnership. 
An IRB-approved flyer (with brief 
inclusion/exclusion criteria) will be 
created and placed in community 
spaces with the help of our community 
partners. Community members who 
are interested in the study, and who 
are also part of DUHS, will be provided with a study contact number to let us know of their interest. We will use 
the EHR to determine their eligibility, and if eligible, consent will be obtained as above. 
Baseline surveys will be conducted by phone or completed online via Duke REDCap. For participants 
completing surveys by phone, we will ensure that a copy of the survey is mailed or emailed in advance, in case 
participants prefer to review content in advance. We will survey: self-efficacy,18 and quality of life surveys19). 
The most recent BMI in the EHR will be used for the purpose of characterizing the participant population – if 
there is no BMI documented within 1 year of enrollment, we will count BMI data as missing. For HbA1c, if there 
is no documented HbA1c within 3 months of enrollment to the study, or ALT and ALT within 6 months of 
enrollment, we will order these tests to be completed at baseline.  
 
Table 1: NAFLD-DM study visits and timing 
Months 
0 
1 
2 
3 
Enrollment, consent review (~20 min, remote visit) 
x 
 
 
 
Surveys (~20-30 min, online or on phone) 
x 
 
 
x 
NAFLD education (~30 min, remotely) 
x 
 
 
 
Diet and lifestyle support (~30 min each, remotely) 
x 
x 
x 
 
Medication changes (~20 min, remotely) * 
o 
o 
o o 
If indicated, ordering tests and referrals * 
o 
o 
o o 
Interviews (~30 min, remotely) 
 
 
 
x 
*Timing of med changes and ordering of tests/referrals will vary by participant. 
x Visits that will occur for all participants. 
o Visits that may or may not occur and are dependent upon individual needs. 


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Evidence-based care of NAFLD in T2D: Intervention content will include: 1) NAFLD education; 2) 
diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care. Dr. 
Alexopoulos (PI) and the Clinical Research Coordinator (CRC) will deliver NAFLD education and diet/lifestyle 
support content. Dr. Alexopoulos (PI) will conduct medication management, which will involve review of 
glycemic trends, assessment of hypoglycemia and adjustment of the T2D regimen to accommodate initiation of 
pioglitazone, GLP-1RA and/or SGLT2i. The order in which these medications are considered will depend on 
clinical judgement, patient preference and cost, but GLP-1RA will be prioritized as appropriate, since this class 
has potent weight loss effects.16 Also, at baseline (and as indicated throughout the study), Dr. Alexopoulos (PI) 
will review clinical data and order clinically-indicated liver testing based on guidelines. Surveys and clinical 
evaluation will be repeated at study conclusion. A treatment acceptability measure (TAP) 20 will be 
administered at conclusion to gauge intervention acceptability. A detailed summary of data collection and 
outcome measures can be seen in Table 3. 
 
Table 3: Detailed summary of data collection 
and outcomes 
Method 
Timing 
Primary outcomes 
Feasibility 
System-level NAFLD detection  
Patients who met criteria for NAFLD 
after chart review / total number of 
potentially-eligible patients based 
on our EHR criteria 
3 months 
Recruitment rate* 
Patients eligible and sent letter or 
MyChart message / Patients 
enrolled  
3 months 
Retention rate 
Patients enrolled / Patients 
completed study 
3 months 
Visit completion rate 
Total study visits completed / total 
study visits scheduled 
3 months 
Acceptability 
 
TAP measure20 
3 months 
 
Qualitative interviews 
3 months 
Secondary outcomes of interest 
Medication changes made during the study 
 
Study visit notes in EHR 
0, 3 months 
Proportion of patients in whom clinically-
indicated tests were ordered (e.g. labs, referral, 
imaging).   
Study visit notes in HER 
0, 3 months 
Psychosocial constructs 
Self-efficacy 
Autonomy support 
Quality of life 
 
6-item SEMCD21 
HCCQ Diabetes18 
SF-1219 
 
0,3 months 
Descriptive data to characterize population 
Social and demographic 
Age, sex, race/ethnicity, marital status, 
education, employment, tobacco use, 
alcohol use, SDOH screen (food 
insecurity, housing instability, lack of 
transportation) 
Self-reported surveys 
0 months 
Health literacy/numeracy 
NVS 
0 months 
Medication adherence 
VMNQ22 
0 months 
Clinical 
Baseline knowledge of NAFLD, years 
with diabetes, medical history, 
medication use 
Self-reported surveys 
0 months 


Improving detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 
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PI: Anastasia-Stefania Alexopoulos, MD 
 
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Labs: HbA1c, AST, ALT 
Use from EHR if collected within 3 
months of baseline visit. Otherwise, 
research labs collected in DUHS at 
specified time points. 
 
0 months 
Biomedical 
Height, weight, BMI 
From EHR (last recorded values) 
0 months 
*We will also track the number of participants who expressed interest in the study based on our recruitment flyer, and 
examine the recruitment rate via this approach (i.e., patients who expressed interest / patients enrolled. Abbreviations: 
TAP=Treatment Acceptability & Preferences; SDOH=social determinates of health; NAFLD=nonalcoholic fatty liver 
disease; BMI=body mass index; HER=electronic health record; SEMCD=Self-efficacy to Manage Chronic Disease 
Scale; VMNQ=Voils Medication Non-Adherence Questionnaire; NVS=Newest Vital Sign; HCCQ=Healthcare Climate 
Questionnaire.  
Participant interviews: At study conclusion, individual 30-minute virtual interviews will be conducted with all 
study participants. The primary purpose will be to assess intervention acceptability and to gain specific 
feedback about intervention content. Thematic saturation is expected by 12 interviews.22  
 
Quantitative analysis: Intervention feasibility will be evaluated by examining recruitment rates, retention rates, 
and  study visit completion rates. For the TAP measure, mean score and standard deviation will be calculated. 
This feasibility pilot will not be powered to examine changes in clinical measures (e.g., HbA1c, ALT).  
 
Qualitative analysis: All interviews will be digitally recorded and transcribed. Transcripts will be analyzed with 
direct content analysis.23  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Improving detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 
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PI: Anastasia-Stefania Alexopoulos, MD 
 
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