Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling
The goal of this intervention study is to learn about how weight loss impacts molecular signaling of intermuscular adipose tissue (IMAT) in individuals with obesity. The main question it aims to answer is how inflammatory molecules secreted by IMAT promote muscle insulin resistance and inflammation, and how these same molecules are diminished after weight loss. Following screening visits involving body composition measures, blood testing, strength testing, and a thigh muscle biopsy, participants will go through a 12-week dietary intervention for weight loss. After 12 weeks, this will be followed by the same testing and biopsies that were completed before the intervention. Researchers will then compare outcomes of individuals who lost weight to individuals who did not lose weight.
Conditions:
🦠 Obesity 🦠 Insulin Sensitivity 🦠 Muscle Weakness 🦠 Adiposity 🦠 Insulin Resistance
🗓️ Study Start (Actual) 1 January 2024
🗓️ Primary Completion (Estimated) 1 December 2028
✅ Study Completion (Estimated) 1 December 2029
👥 Enrollment (Estimated) 70
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Generally healthy men and women aged 18-70
    • * BMI between 30-40
    • * Less than 1 hour of exercise per week
    • * Women:
    • 1. may be pre or post menopausal

    Exclusion Criteria:

    • * Type 1 or Type 2 diabetes
    • * Thyroid disease
    • * History of lung disease
    • * Active use of nicotine
    • * Severe plasma lipid disorders
    • * Taking hormone replacement drugs, blood thinners, or thiazoladinediones
    • * Women:
    • 1. Currently going through menopause or peri-menopause
    • 2. Pregnant or breastfeeding
    • 3. History of Polycystic Ovary Syndrome
Ages Eligible for Study: 18 Years to 70 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 8 November 2023
  • First Submitted that Met QC Criteria 10 November 2023
  • First Posted 13 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 April 2024
  • Last Update Posted 23 April 2024
  • Last Verified April 2024