Clinical trial NCT06177210: Type 2 Diabetes Remission
Official title: Putting Type 2 Diabetes Into Remission: Developing a Person-centred, Interdisciplinary Nutrition Intervention
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Type 2 Diabetes Mellitus Remission
Keywords: type 2 diabetes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Manitoba
First posted: 2023-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who achieved T2D remission

Brief summary: The study aims to establish a cohort of patients with type 2 diabetes (T2D) who have achieved remission through lifestyle intervention or bariatric surgery. Remission is defined as a return of HbA1c to less than 6.5% that occurs spontaneously or following an intervention and in the absence of usual glucose-lowering pharmacotherapy for at least 3 months.

Detailed description: The first aim of the study will be to recruit individuals (initial recruitment N=10-12 per group) with physician diagnosed T2D who have achieved remission (HbA1c less than 6.5% and absence of glucose-lowering pharmacotherapy for at least 3 months) through lifestyle interventions or bariatric surgery.

Participants will be recruited by Dr Oliveira:

* from past trials: from previous Informed consent document with ethics approval, Dr Oliveira will approach participants directly through individual email to advise them that a study is being conducted and to enquire if the participant would like to find out more information concerning it.
* via partner/stakeholder networks - Healthcare professionals (e.g., private physician, dietitian, or pharmacist offices): permission to release the contact information will be obtained from the participant by the healthcare professionals before the researcher can use the information for recruitment purposes. The healthcare professionals will either verbally ask the prospective participants' permission to release their names to the Investigator, or distribute an introductory letter describing the study to the prospective participants, with details on how to contact the Investigator if they are interested in participating.
* online advertising: the recruitment poster as per section 9, will be posted on local online newspapers and by posting Recruitment poster on social media.
* website recruitment: https://diabeticstudy.net/index.htm
* In Manitoba: via a recruitment poster as per section 9 that will be circulated via social media and a Letter of initial contact which will be sent to people who express interest in participating.

Inclusion criteria:

1. Have previously been diagnosed with T2D;
2. Have achieved diabetes remission (HbA1c below 6.5% and no glucose lowering medications for at least 3 months)through lifestyle intervention or Bariatric surgery

Exclusion criteria:

1. Have not been diagnosed with T2D;
2. Have an HbA1c level higher than 6.5%;
3. Are taking any glucose lowering medications;
4. Are ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders;
5. Are unable to follow remote guidance by internet or smartphone;
6. Are unable to read or communicate in English.

If demonstrated interest, participants will receive a copy of the Informed Consent by email for their review. If agreed, exclusion and inclusion criteria will be then assessed by completion of an Eligibility Questionnaire and upon confirmation of eligibility, an Electronic Consent form will be signed. The lead researchers will then ensure that the participants understand the details of the study via phone or Zoom call, while asking for confirmation of remission status based on a recent (within 1 month) laboratory A1c value (which is routinely collected by family physicians as part of T2D care). Participants in BC without a current laboratory A1c value will be suggested to ask for an exam request from their family doctor.

Participants will then answer a package of questionnaires:

1. Health Screening Questionnaire + Remission Survey (Lifestyle intervention or Bariatric surgery)
2. Pittsburgh Sleep Quality Index (PSQI)
3. Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ)
4. EQ-5D-5L - Describe and Value Health
5. Three-Factor Eating Questionnaire
6. Perceived Stress Scale

All questionnaires and forms will be sent by REDCap-UBC links and are designed to capture baseline characteristics related to T2D and lifestyle that could influence (or be influenced by) remission.

The second aim of the study is to determine glucose profiles of participants from both groups through CGM.

Participants will receive a study kit at their homes containing a FreeStyle Libre IQ - Continuous Glucose Monitor (CGM) Reader and Sensor, Diet Record papers, and a pre-paid mail envelope. CGM instructions will be sent with the kit and a Zoom meeting can be scheduled to help participants with self-insertion of the device, which is designed to be inserted by persons living with T2D on their own. After completion of the 14-day use, the CGM sensor and reader will be sent back by mail. CGM will serve to confirm some glucose remission criteria stated by the Consensus Report from American Diabetes Association1: mean daily glucose \<7.0 mmol/L and 24-h mean glucose concentrations as an estimated HbA1c (eA1C) or most recently named as a glucose management indicator (GMI) \<6.5%. The research team is experienced in CGM data collection and analyses having conducted \>10 CGM-based studies in the last 8 years.10,11 Once CGM data are analyzed, the research team with follow-up with a Zoom interview in a subsample (n=4-6) of participants in each remission strategy group (lifestyle vs surgery) at each site (n=24 in total). The semi-structured interview will consist of questions that investigate what were the person-level challenges and solutions toward achieving T2D remission. Participants will self-identify in the original consent form if they are willing to participate in the interview portion and the qualitative participants will be recruited based on the lowest and highest values from the CGM analysis (either mean glucose, time-in-range, or glucose standard deviation) whichever gives the largest distribution, the highest and lowest 2-3 from each group (bariatric surgery vs lifestyle) at each site will constitute the sub-sample.

The third aim of the study will be to combine these data with our team's expertise in dietetics, psychology/behavior change, and healthcare delivery, and develop an intervention that meets the needs of patients and healthcare providers that can be embedded into the healthcare system.

The fourth aim (Annual follow-up) is to contact participants from T2D remission cohort for subsequent follow-up, after 1 year. Only participants who consented for future contact and potential future sub-studies that may be conducted once the cohort is established (as per Informed Consent page 5), will be approached. Participation in follow-up study will not be mandatory. Protocol will be similar to first aim study.

Eligibility criteria: Inclusion Criteria:

1. Have previously been diagnosed with T2D;
2. Have achieved diabetes remission (HbA1c below 6.5% and no glucose-lowering medications for at least 3 months) through lifestyle intervention and bariatric surgery.

Exclusion Criteria:

1. Have not been diagnosed with T2D;
2. Have an HbA1c level higher than 6.5%;
3. Are taking any glucose-lowering medications;
4. Are ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders;
5. Are unable to follow remote guidance by internet or smartphone;
6. Are unable to read or communicate in English.

Primary outcomes:
measure: Establish a cohort of participants who achieved T2D remission through lifestyle interventions
timeFrame: Baseline and after 1 year.
measure: Establish a cohort of participants who achieved T2D remission through bariatric surgery
timeFrame: Baseline and after 1 year.
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: Baseline and after 1 year.
measure: Questionnaires -Health Screening Questionnaire
timeFrame: Baseline and after 1 year.
measure: Questionnaires - Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and after 1 year.
measure: Questionnaires - Perceived Stress Scale
timeFrame: Baseline and after 1 year.
measure: Questionnaires - Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ)
timeFrame: Baseline and after 1 year.
measure: Questionnaires - EQ-5D-5L
timeFrame: Baseline and after 1 year.
measure: Questionnaires - Three-Factor Eating Questionnaire (TFEQ)
timeFrame: Baseline and after 1 year.
measure: Questionnaires - Remission survey (Bariatric surgery)
timeFrame: Baseline and after 1 year.
measure: Questionnaires - Remission survey (Lifestyle intervention)
timeFrame: Baseline and after 1 year.
measure: Mean Sensor glucose
timeFrame: Baseline and after 1 year.
measure: Minimum sensor glucose
timeFrame: Baseline and after 1 year.
measure: Maximum sensor glucose
timeFrame: Baseline and after 1 year.
measure: Day time average glucose
timeFrame: Baseline and after 1 year.
measure: Standard Deviation (SD)
timeFrame: Baseline and after 1 year.
measure: Coefficient of variation (CV)
timeFrame: Baseline and after 1 year.
measure: Glucose Management Indicator (GMI)
timeFrame: Baseline and after 1 year.
measure: Qualitative interviews
timeFrame: Baseline and after 1 year.
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
References: