NCT06682351

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prediabetes / Type 2 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study