Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
Stanford University
110 participants
Jan 31, 2019
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
Inclusion Criteria4
- Age 35-65
- BMI 25-35 kg/m2
- Stable body weight
- Nondiabetic
Exclusion Criteria12
- 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
Interventions
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.
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.
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)
View Full Details on ClinicalTrials.gov
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NCT05165706