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NOT YET RECRUITING
NCT06682351
PHASE4

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

Sponsor: Stanford University

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-11

Completion Date

2027-12

Last Updated

2024-11-12

Healthy Volunteers

No

Interventions

DRUG

Metformin

16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.

DRUG

GLP-1A

16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.

DIETARY_SUPPLEMENT

MED

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.

Locations (1)

Stanford University

Stanford, California, United States