GLP-1A + Metformin + Mediterranean Diet for Prediabetes

Recruiting in Palo Alto (17 mi)

Overseen byTracey L McLaughlin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study team will invite participants with prediabetes or mild diabetes (HbA1c 5.7-7.0) to join a 5-year research study that will define subphenotypes of type 2 diabetes based on underlying physiology (eg insulin resistance, beta-cell dysfunction, incretin defect, liver insulin resistance) and then test the hypothesis that response to three first-line treatments will vary according to metabolic subphenotype. Variables of interest include glucose, cardiovascular risk markers, and weight. Treatments include Mediterranean diet, metformin, and a GLP-1 agonist. Participants will go through an initial screening, followed by three treatment periods, each lasting 4 months with 3 month washout in-between treatment periods. This study will help us understand how personalized treatments can help control blood glucose, reduce cardiovascular risk, and manage weight. While there may be minor side effects-like slight discomfort from blood tests, gastrointestinal symptoms from some of the medications, and small radiation exposure from DXA body scans-the treatments offered in this study have all been well studied and are known to lower risk for diabetes and cardiovascular disease

Eligibility Criteria

This trial is for individuals with prediabetes or mild diabetes (HbA1c levels between 5.7-7.0). It aims to identify different subtypes of type 2 diabetes and tailor treatments accordingly. Participants will undergo a series of tests and receive three first-line treatments: a Mediterranean diet, metformin, and a GLP-1 agonist over the course of five years.

Inclusion Criteria

My HbA1c level is between 5.7% and 8.0%, and I'm not taking diabetes medication.

My BMI is between 23 and 45, or between 22 and 45 if I'm Asian.

Exclusion Criteria

I do not have a history of cancer, kidney/liver disease, pregnancy, chronic inflammation, eating disorders, or bariatric surgery.

Physical activity >2 hours/day

I had a heart or blood vessel event in the last 6 months.

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Treatment Details

Interventions

GLP-1A (GLP-1 agonist)
Mediterranean Diet (Behavioural Intervention)
Metformin (Biguanide)

Trial OverviewThe study is testing how well participants with varying underlying diabetic physiology respond to three interventions: dietary changes through the Mediterranean diet, the medication metformin, and GLP-1 agonists—a type of medication that affects insulin secretion. The goal is to see which treatment works best for specific diabetic subphenotypes.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Metformin/Mediterranean Diet/GLP1aExperimental Treatment3 Interventions

1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. 2. 3 months washout 3. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat. 4. 3 months washout 5. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.

Group II: Mediterranean Diet/GLP1a/MetforminExperimental Treatment3 Interventions

1. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat. 2. 3 months washout 3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 4. 3 months washout 5. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.

Group III: GLP1a/Metformin/Mediterranean DietExperimental Treatment3 Interventions

1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 2. 3 months washout 3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. 4. 3 months washout 5. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.