Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
Recruiting · NCT05165706 · Interventional (participants receive a specific treatment) · Lead sponsor: Stanford University
View the official record on ClinicalTrials.gov →Interventions studied
Dietary Intervention Mediterranean Low Carbohydrate DietDietary Intervention Standard Low Carbohydrate DietDietary Intervention Standard Low Fat Diet
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.
Who can take part
Age range
35 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Stanford University - Stanford, California, United States