RecruitingNot ApplicableNCT05165706

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


Sponsor

Stanford University

Enrollment

110 participants

Start Date

Jan 31, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 35 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the biological mechanisms behind insulin resistance in people who are overweight or mildly obese but not yet diabetic. Researchers will take blood, tissue, and other biological samples over time to understand how fat and metabolism contribute to early diabetes risk. **You may be eligible if...** - You are 35–65 years old - Your BMI is between 25 and 35 - Your weight has been stable recently (no significant changes in the past 12 weeks) - You do not have diabetes **You may NOT be eligible if...** - You have diabetes or very high fasting blood sugar - You have a major organ disease - You have had bariatric surgery or liposuction - You have an active eating disorder or serious psychiatric condition - You are pregnant, breastfeeding, or drink heavily - You take weight loss medications, statins, or oral steroids - Your blood pressure is higher than 160/100 mmHg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDietary Intervention Mediterranean Low Carbohydrate Diet

Assigned participants will receive instruction by a registered dietitian on a diet that is high in unsaturated fats and low in carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.

BEHAVIORALDietary Intervention Standard Low Carbohydrate Diet

Assigned participants will receive instruction by a registered dietitian on a low carbohydrate diet that is high in fats found in the typical American diet. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.

BEHAVIORALDietary Intervention Standard Low Fat Diet

Assigned participants will receive instruction by a registered dietitian on a low fat diet that is high in complex carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.


Locations(1)

Stanford University

Stanford, California, United States

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NCT05165706


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