Clinical trial NCT06682351: Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention
Official title: Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Prediabetes / Type 2 Diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* BMI ≥23 (≥22 in Asians) kg/m2 but \< 45 kg/m2
* HbA1c 5.7-8.0% while not on antihyperglycemic medications

Exclusion Criteria:

* 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
* current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician)
* heavy alcohol use
* hct \<30, creatinine \> 1.4, ALT\> 3x ULN
* physical activity \>2 hours/day
* inability to come to Stanford CTRU for metabolic testing

Primary outcomes:
measure: Change in HbA1c
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
Secondary outcomes:
measure: Change in Time in Range (TIR)
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: Change in body weight
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: Change in Blood Pressure
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: Change in LDL Cholesterol
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: Change in Triglycerides
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: Change in high-sensitivity C-reactive protein (hsCRP)
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: Change in alanine transaminase (ALT)
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: Change in adiponectin
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: HOMA-B
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: HOMA-IR
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
measure: Change in body fat mass
timeFrame: At month 0, month 4, month 8, month 11, month 15, month 18
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Tracey McLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
References: