NCT06682351Not yet recruitingPhase 4
Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention
Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- Nov 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Stanford University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06682351
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From Nov 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician)
Other illness
- 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
Lab values
- hct \<30, creatinine \> 1.4, ALT\> 3x ULN
Other
- Recent (\<6mos) CVD event
- heavy alcohol use
- physical activity \>2 hours/day
- inability to come to Stanford CTRU for metabolic testing
Who the study is looking for
- BMI ≥23 (≥22 in Asians) kg/m2 but \< 45 kg/m2
- HbA1c 5.7-8.0% while not on antihyperglycemic medications
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.