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Recruiting NCT05165706

Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance

Trial Parameters

Condition Diabetes Mellitus, Type 2
Sponsor Stanford University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 110
Sex ALL
Min Age 35 Years
Max Age 65 Years
Start Date 2019-01-31
Completion 2026-11-30
Interventions
Dietary Intervention Mediterranean Low Carbohydrate DietDietary Intervention Standard Low Carbohydrate DietDietary Intervention Standard Low Fat Diet

Brief Summary

This 12-week controlled diet and weight intervention study seeks to define the molecular pathways that link excess body weight to the development of insulin resistance (IR). Blood, adipose and stool are sampled at three timepoints; baseline, peak weight (4 weeks) and post weight loss to monitor changes in cellular processes. Additionally, direct insulin sensitivity testing, and radiological measurement of visceral fat and intrahepatic fat content is measured at three timepoints to correlate clinical indices with cellular changes.

Eligibility Criteria

Inclusion Criteria: * Age 35-65 * BMI 25-35 kg/m2 * Stable body weight * Nondiabetic Exclusion Criteria: Patients with; * diabetes * major organ disease * history of liposuction or bariatric surgery * active eating or psychiatric disorder * pregnancy or lactation, heavy alcohol use * recent change in weight (over the past 12 weeks) * use of weight loss medication, statins, or oral steroids Clinical screening exclusions; * hematocrit \< 33% * fasting glucose \>/= 126 mg/dL * blood pressure \>160/100 mmHg

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