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NCT Number: NCT06682351

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

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

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Key information

Conditions

Prediabetes / Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University

Stanford, California, 94305, United States

Location contact

Alina Choi, BS

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Other names: MET

GLP-1A

Drug

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

Other names: Glucagon-like peptide-1 analog

MED

Dietary Supplement

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.

Other names: Mediterranean Diet, energy-restricted Mediterranean diet

Primary outcomes

  1. Change in HbA1c

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    The study team will compare the change in HbA1c levels from beginning to end of intervention to compare the efficacy of each treatment.

Secondary outcomes

  1. Change in Time in Range (TIR)

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    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.

  2. Change in body weight

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    Compare efficacy of each treatment in change in body weight (kg).

  3. Change in Blood Pressure

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    Compare efficacy of each treatment in change in blood pressure.

  4. Change in LDL Cholesterol

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    Change in LDL cholesterol at the beginning and end of each intervention to compare the efficacy of each treatment.

  5. Change in Triglycerides

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    Change in triglycerides at the beginning and end of each intervention period to compare the efficacy of each treatment.

  6. Change in high-sensitivity C-reactive protein (hsCRP)

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    hsCRP will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment.

  7. Change in alanine transaminase (ALT)

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    ALT will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment.

  8. Change in adiponectin

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    Adiponectin will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment.

  9. HOMA-B

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    Change from baseline in HOMA-B at the beginning and end of each intervention period to compare the efficacy of each treatment.

  10. HOMA-IR

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    Change from baseline in HOMA-IR at the beginning and end of each intervention period to compare the efficacy of each treatment.

  11. Change in body fat mass

    Time frame: At month 0, month 4, month 8, month 11, month 15, month 18

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alina Choi, BS

CONTACT

[email protected]

7144884516

Jasmine Yang, BA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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