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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorStanford University

About this trial

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

Qualifiers

Age 35-65

BMI 25-35 kg/m2

Stable body weight

Nondiabetic

Disqualifiers

diabetes

major organ disease

history of liposuction or bariatric surgery

active eating or psychiatric disorder

Trial design

Treatments tested in this trial

  • Dietary Intervention Mediterranean Low Carbohydrate Diet
  • Dietary Intervention Standard Low Carbohydrate Diet
  • Dietary Intervention Standard Low Fat Diet

Treatment groups

110 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator