Actively Recruiting

Phase Not Applicable
Age: 35Years - 65Years
All Genders
Healthy Volunteers
NCT05165706

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

Led by Stanford University · Updated on 2024-12-04

110

Participants Needed

1

Research Sites

412 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 35Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 35-65
  • Body mass index (BMI) between 25 and 35 kg/m2
  • Stable body weight
  • Nondiabetic
Not Eligible

You will not qualify if you...

  • Diagnosis of 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 within the past 12 weeks
  • Use of weight loss medication, statins, or oral steroids
  • Hematocrit less than 33%
  • Fasting glucose 126 mg/dL or higher
  • Blood pressure higher than 160/100 mmHg

AI-Screening

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Trial Site Locations

Total: 1 location

1

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

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Research Team

E

Ekrem M Ayhan, BS

CONTACT

D

Dalia Perelman, MS, RD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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