Clinical trial NCT04343872: Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach Rural Communities at High Risk.
Official title: UAB Diabetes Research Center (DRC): Chronic Disease and the Reduction of Health Disparities Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Keywords: Obesity
Metformin Therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-04-13
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Diabetes is responsible for a huge and growing burden of patient suffering and social costs, and the impact of this disease is shared disproportionately by minorities and in rural resource-challenged communities, particularly in the Deep South. To address this problem, the University of Alabama (UAB) Diabetes Research Center (DRC) will establish a primary care clinical network in rural counties of Alabama and in the Mississippi delta that will provide the (DRC) and its members with opportunities for partnership and the infrastructure to conduct translational and clinical research in those patients with the greatest need. A pilot trial will be conducted within the coalition to assess feasibility for a larger trial to evaluate a novel and sustainable approach for diabetes prevention that involves an innovative lifestyle intervention combined with metformin.

Detailed description: The pilot trial in aim three will include enrolling four primary care practices. Each of the participating practices will be randomized to one of two arms and accordingly enrolled participants from each clinic will be assigned to one of two conditions:

Condition 1. Receive lifestyle modification alone (Diabetes Prevention Program (DPP).

Condition 2. Receive lifestyle modification (DPP) with metformin therapy recommendation.

Twenty five participants will be enrolled from each participating practice. Participants will be followed up for 12-14 months after recruitment.

Eligibility criteria: Inclusion Criteria:

* Age 19 to 65 years
* Body mass index (BMI) ≥30
* Receives care at one of the participating primary care clinics
* HbA1c 6.0% to 6.4%
* Resides in one location at least 5 days each week
* Willing to attend group-based classes
* Willing to work with a peer advisor in-person and over the phone
* Has regular access to telephone or cellular phone
* Willing and able to use telemonitoring body weight to conduct daily self-weighing
* Estimated Glomerular Filtration Rate (eGFR) of ≥60 in their medical record within 6 months

Exclusion Criteria:

* Diabetes diagnosis or HbA1c \>6.4% or fasting glucose ≥126
* HbA1c \<6.0%
* Pregnancy or anticipating pregnancy
* Unwilling or unable to do any of the following: give informed consent, accept random assignment, allow study staff to visit them at their primary care clinic for two follow-up visits
* Likely to relocate within next 6 months and no longer be seen at clinic within the next 12 months
* Weight loss ≥5% of body weight in past 6 months (other than postpartum)
* Past bariatric surgery
* Prescription weight loss medications within the past 6 months
* eGFR \< 60 within past 6 months
* Unable to ambulate
* Have end-stage medical conditions with limited life expectancy

Primary outcomes:
measure: Change in Body Weight
timeFrame: 12 months
measure: Change in Glycosylated Hemoglobin (HbA1c)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrea Cherrington, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: