Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT05165706

Conditions

Diabetes Mellitus, Type 2

PreDiabetes

Insulin Resistance

Obesity

Nonalcoholic Steatohepatitis

Eligibility Criteria

Sex: All

Age: 35 - 65

Healthy Volunteers: Accepted

Interventions

Dietary Intervention Mediterranean Low Carbohydrate Diet

Dietary Intervention Standard Low Carbohydrate Diet

Dietary Intervention Standard Low Fat Diet

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 2

PreDiabetes

Insulin Resistance

Obesity

Nonalcoholic Steatohepatitis

Study ID

NCT05165706

Start date

Jan 31, 2019

Status verified date

Dec, 2024

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: Low Fat, Healthy Carbohydrate 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.

Interventions

Dietary 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.

Dietary 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.

Dietary 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.

Primary outcome measure

  • Change from baseline on the 2-stage Steady State Plasma Glucose test [ Time Frame: Peak weight (4 weeks) ]
  • Change from baseline on the radiographic measurement of visceral to subcutaneous (V:S) fat ratio [ Time Frame: Peak weight (4 weeks) ]
  • Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid deposition [ Time Frame: Peak weight (4 weeks) ]
  • Change from peak weight on the 2-stage Steady State Plasma Glucose test [ Time Frame: Post-weight loss (8 weeks) ]
  • Change from baseline on the radiographic measurement of visceral to subcutaneous (V:S) fat ratio [ Time Frame: Post-weight loss (8 weeks) ]
  • Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid deposition [ Time Frame: Post-weight loss (8 weeks) ]
  • Measurement of markers of lipid and carbohydrate metabolism and inflammation from adipose mRNA [ Time Frame: Baseline ]
  • Quantification of plasma inflammatory cytokine levels in serum samples by Luminex immunoassay [ Time Frame: Baseline ]
  • Change from baseline in plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay [ Time Frame: Peak Weight (4 weeks) ]

Central Contacts and Locations

Central contacts

Ekrem M Ayhan, BS

908-619-5381ayhane@stanford.edu

Dalia Perelman, MS, RD

daliap@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Ekrem M Ayhan, BS

908-619-5381ayhane@stanford.edu

Dalia Perelman, MS, RD

daliap@stanford.edu

Principal Investigator:

Tracey L McLaughlin, MD, MS

More Information

Sponsor

Stanford University

Last update posted

Dec 4, 2024

Last verified

Dec, 2024

Keywords

  • Metabolomics
  • Low Fat Diet
  • Low Carbohydrate Diet
  • Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-12-04.