Clinical trial Recruiting at 1 site Interventional Ages 35 to 65

Understanding how obesity affects insulin resistance through diet and molecular profiling

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

Run by Stanford University · NCT05165706 · Data updated 2026-11-12

This study is trying to see how different diets can affect insulin resistance in people with obesity by looking at changes in their body and blood over 12 weeks.

Quick facts

Study typeInterventional
Ages35 Years to 65 Years
SexAll
Enrollment110 (estimated)
SponsorStanford University
Academic / other
Locations1 site (Stanford, California)
StatusRecruiting
StartedJanuary 31, 2019
Main results expectedNovember 30, 2026
Study endsDecember 30, 2026
Registry record updatedDecember 4, 2024
Trial IDNCT05165706 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 35-65 with a BMI between 25-35 kg/m2 who are nondiabetic and have stable body weight.

Probably not a fit

Patients with diabetes, major organ diseases, or those who have undergone weight loss surgeries will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This 12-week intervention focuses on the molecular pathways linking obesity to insulin resistance by employing a controlled diet and weight intervention. Participants will undergo blood, adipose, and stool sampling at three timepoints to monitor changes in cellular processes, alongside direct insulin sensitivity testing and imaging of fat content. The study aims to differentiate between insulin resistant and insulin sensitive individuals with similar obesity profiles, utilizing an integrated omics strategy to uncover the underlying biological mechanisms. By analyzing the effects of various dietary interventions, the research seeks to enhance our understanding of obesity's impact on metabolic health.

Why it matters

Potential benefit: If successful, this study could lead to personalized dietary recommendations that improve insulin sensitivity and metabolic health in individuals with obesity.

How similar studies have gone: Other studies have shown success in using dietary interventions to improve insulin sensitivity, making this approach both relevant and promising.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Stanford University
    Stanford, California, United States
    Recruiting

Study contacts

  • Principal investigator: Tracey McLaughlin, MD — Stanford University, Department of Medicine, Division of Endocrinology
  • Study coordinator: Ekrem M Ayhan, BS
  • Email: ayhane@stanford.edu
  • Phone: 908-619-5381

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.