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Clinical Trial NCT06682351 for Prediabetes / Type 2 Diabetes is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Stanford UniversityHeterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention Phase 4 200 Dietary Personalized Treatment Prevention
Clinical Trial NCT06682351 is designed to study Treatment for Prediabetes / Type 2 Diabetes. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on November 1, 2024 until the study accrues 200 participants. Led by Stanford University, this study is expected to complete by December 1, 2027. The latest data from ClinicalTrials.gov was last updated on November 12, 2024.
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. Variab...Show More
Official Title
Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention
Conditions
Prediabetes / Type 2 DiabetesOther Study IDs
- 76481
NCT ID Number
Start Date (Actual)
2024-11
Last Update Posted
2024-11-12
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalMediterranean Diet/GLP1a/Metformin 1. 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.
2. 3 months washout
3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
4. 3 months washout
5. 16 weeks of using metformi...Show More | Metformin 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. GLP-1A 16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 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. |
ExperimentalMetformin/Mediterranean Diet/GLP1a 1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
2. 3 months washout
3. 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.
4. 3 months washout
5. 16 weeks using GLP1 agonist: Dosing will...Show More | Metformin 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. GLP-1A 16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 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. |
ExperimentalGLP1a/Metformin/Mediterranean Diet 1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
2. 3 months washout
3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
4. 3 months washout
5. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and s...Show More | Metformin 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. GLP-1A 16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | At month 0, month 4, month 8, month 11, month 15, month 18 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Time in Range (TIR) | Change in Time in Rage (TIR) as measured by continuous glucose monitor (CGM). TIR is defined as a range of 70-140 mg/dL. The study team will calculate the changes from beginning to end or each intervention and compare efficacy of each treatment in TIR. | At month 0, month 4, month 8, month 11, month 15, month 18 |
Change in body weight | Compare efficacy of each treatment in change in body weight (kg). | At month 0, month 4, month 8, month 11, month 15, month 18 |
Change in Blood Pressure | Compare efficacy of each treatment in change in blood pressure. | At month 0, month 4, month 8, month 11, month 15, month 18 |
Change in LDL Cholesterol | Change in LDL cholesterol at the beginning and end of each intervention to compare the efficacy of each treatment. | At month 0, month 4, month 8, month 11, month 15, month 18 |
Change in Triglycerides | Change in triglycerides at the beginning and end of each intervention period to compare the efficacy of each treatment. | At month 0, month 4, month 8, month 11, month 15, month 18 |
Change in high-sensitivity C-reactive protein (hsCRP) | hsCRP will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment. | At month 0, month 4, month 8, month 11, month 15, month 18 |
Change in alanine transaminase (ALT) | ALT will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment. | At month 0, month 4, month 8, month 11, month 15, month 18 |
Change in adiponectin | Adiponectin will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment. | At month 0, month 4, month 8, month 11, month 15, month 18 |
HOMA-B | Change from baseline in HOMA-B at the beginning and end of each intervention period to compare the efficacy of each treatment. | At month 0, month 4, month 8, month 11, month 15, month 18 |
HOMA-IR | Change from baseline in HOMA-IR at the beginning and end of each intervention period to compare the efficacy of each treatment. | At month 0, month 4, month 8, month 11, month 15, month 18 |
Change in body fat mass | Body fat mass will be measured by dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of each intervention period to compare the efficacy of each treatment. | At month 0, month 4, month 8, month 11, month 15, month 18 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- BMI ≥23 (≥22 in Asians) kg/m2 but < 45 kg/m2
- HbA1c 5.7-8.0% while not on antihyperglycemic medications
- 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
Stanford University665 active studies to exploreStudy Responsible Party
Tracey McLaughlin, Principal Investigator, Professor of Medicine (Endocrinology), Stanford University
Study Central Contact
Contact: Alina Choi, BS, 7144884516, [email protected]
Contact: Jasmine Yang, BA, [email protected]
1 Study Locations in 1 Countries
California
Stanford University, Stanford, California, 94305, United States
Alina Choi, BS, Contact, [email protected]