Obesity Clinical Trial
Official title:
Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline on the 2-stage Steady State Plasma Glucose test | Compare direct measurement of insulin sensitivity after 4 week diet and weight intervention | Peak weight (4 weeks) | |
Primary | Change from baseline on the radiographic measurement of visceral to subcutaneous (V:S) fat ratio | Compare measurement of abdominal V:S fat volume via computed tomography (CT) after 4 week diet and weight intervention | Peak weight (4 weeks) | |
Primary | Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid deposition | Compare measurement of liver fat content via magnetic resonance spectroscopy (MRS) after 4 week diet and weight intervention | Peak weight (4 weeks) | |
Primary | Change from peak weight on the 2-stage Steady State Plasma Glucose test | Compare direct measurement of insulin sensitivity after 8 week diet and weight intervention | Post-weight loss (8 weeks) | |
Primary | Change from baseline on the radiographic measurement of visceral to subcutaneous (V:S) fat ratio | Compare measurement of abdominal V:S fat volume via computed tomography (CT) after 8 week diet and weight intervention | Post-weight loss (8 weeks) | |
Primary | Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid deposition | Compare measurement of liver fat content via magnetic resonance spectroscopy (MRS) after 8 week diet and weight intervention | Post-weight loss (8 weeks) | |
Primary | Measurement of markers of lipid and carbohydrate metabolism and inflammation from adipose mRNA | Compare adipose tissue transcripts such as known MODY transcription factors, defensin chemokine receptors, and platelet activation factors measured by PCR between participants identified as Insulin sensitive (IS) and Insulin resistant (IR) using the 2-stage Steady State Plasma Glucose test. | Baseline | |
Primary | Quantification of plasma inflammatory cytokine levels in serum samples by Luminex immunoassay | Compare plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay between participants identified as Insulin Sensitive (IS) and Insulin Resistant (IR) using the 2-stage Steady State Plasma Glucose test. | Baseline | |
Primary | Change from baseline in plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay | Compare intra-personal levels of plasma inflammatory cytokines as measured by Luminex immunoassay after 4 week diet and weight intervention | Peak Weight (4 weeks) |
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