Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention

ConditionPrediabetes / Type 2 Diabetes

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-75

SponsorStanford University

About 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 does not accept healthy volunteers

Qualifiers

BMI ≥23 (≥22 in Asians) kg/m2 but < 45 kg/m2

HbA1c 5.7-8.0% while not on antihyperglycemic medications

Disqualifiers

Recent (<6mos) CVD event

active malignancy, kidney/liver disease pregnancy/lactation, chronic inflammatory disease, eating disorder, bariatric surgery

history of acute pancreatitis

family or personal history of medullary thyroid cancer

Trial design

Design model

Crossover

Treatments tested in this trial

Metformin
Drug
16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
GLP-1A
Drug
16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
MED
Dietary supplement
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.

Treatment groups

200 Participants

are divided into 3 treatment groups

Group A: Mediterranean Diet/GLP1a/MetforminExperimental treatment 3 interventions

Group B: Metformin/Mediterranean Diet/GLP1aExperimental treatment 3 interventions

Group C: GLP1a/Metformin/Mediterranean DietExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Change in HbA1c

The study team will compare the change in HbA1c levels from beginning to end of intervention to compare the efficacy of each treatment.

Time frame