Understanding how obesity affects insulin resistance through diet and molecular profiling
Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05165706 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with diabetes, major organ diseases, or those who have undergone weight loss surgeries will not benefit from this study.
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 performed: Other studies have shown success in using dietary interventions to improve insulin sensitivity, making this approach both relevant and promising.
Eligibility criteria
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 this trial is running
Stanford, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.