RECRUITING
I'm interested ...!!
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.
Conditions:
🦠 Diabetes Mellitus, Type 2 🦠 PreDiabetes 🦠 Insulin Resistance 🦠 Obesity 🦠 Nonalcoholic Steatohepatitis 🦠 Nonalcoholic Fatty Liver 🦠 Diet Modification
🗓️ Study Start (Actual) 31 January 2019
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 30 December 2024
👥 Enrollment (Estimated) 110
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Stanford, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 35 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 July 2018
  • First Submitted that Met QC Criteria 7 December 2021
  • First Posted 21 December 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 April 2023
  • Last Update Posted 28 April 2023
  • Last Verified April 2023
I'm interested ...!!