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Search / Trial NCT05165706

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

Launched by STANFORD UNIVERSITY · Dec 7, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Metabolomics Low Fat Diet Low Carbohydrate Diet Microbiome

ClinConnect Summary

This clinical trial is studying how excess body weight can lead to insulin resistance, a condition where the body doesn’t respond well to insulin, which is important for controlling blood sugar levels. The study will last for 12 weeks and involves a controlled diet and weight intervention. Researchers will collect samples of blood, fat tissue, and stool at three different times—when you first join the study, after 4 weeks when you reach your peak weight, and after losing weight—to see how these changes affect your body on a molecular level. They will also measure your body’s response to insulin and check fat levels in the abdomen and liver.

To participate in this study, you need to be between the ages of 35 and 65, have a body mass index (BMI) between 25 and 35 (which means you are overweight), and have had a stable weight recently. You should not have diabetes or any major health issues, and you shouldn’t be pregnant or breastfeeding. If you join, you can expect to follow a specific diet and undergo several tests throughout the study. This trial is currently recruiting participants of all genders, and it aims to understand the relationship between weight and insulin resistance better, which could help in treating conditions like type 2 diabetes and obesity in the future.

Gender

ALL

Eligibility criteria

  • 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

About Stanford University

Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.

Locations

Stanford, California, United States

Patients applied

0 patients applied

Trial Officials

Tracey McLaughlin, MD

Principal Investigator

Stanford University, Department of Medicine, Division of Endocrinology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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