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

Stanford University · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05165706

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 35–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
110
US sites recruiting
1
Study start
January 31, 2019
Record last updated
December 4, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Dietary Intervention Mediterranean Low Carbohydrate Diet; Dietary Intervention Standard Low Carbohydrate Diet; Dietary Intervention Standard Low Fat Diet

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Stanford University

    Stanford, CA 94305

    Site contact: Ekrem M Ayhan, BS · 908-619-5381 · ayhane@stanford.edu

Study contacts (from the official record)

  • Ekrem M Ayhan, BS · 908-619-5381 · ayhane@stanford.edu
  • Dalia Perelman, MS, RD · daliap@stanford.edu
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Longitudinal Multi-Omic Profiles to Reveal Mechanisms of… (NCT05165706) | Bored Studies