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

Recruiting now · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, PreDiabetes, Insulin Resistance, Obesity, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver, Diet Modification

In brief

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.

Key facts

Study ID

NCT05165706

Run by

Stanford University

People needed

110

Starts

2019-01-31

Expected to finish

2026-12-30

Last updated by the study team

2024-12-04

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 35-65
• BMI 25-35 kg/m2
• Stable body weight
• Nondiabetic

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States (enrolling)

Full record on ClinicalTrials.gov

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