Effect of Weight Loss on Intermuscular Adipose Tissue (IMAT) Signaling

NCT ID: NCT06129110

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2029-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Insulin Sensitivity Muscle Weakness Adiposity Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diet Weight Loss

Low calorie meal replacement shakes

Group Type EXPERIMENTAL

Diet Weight Loss

Intervention Type BEHAVIORAL

Low calorie diet of meal replacement shakes

Delayed Intervention

Normal feeding

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diet Weight Loss

Low calorie diet of meal replacement shakes

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Anschutz

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bryan Bergman, PhD

Role: CONTACT

3037243919

Sophia Bowen

Role: CONTACT

3037240487

Facility Contacts

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Bryan Bergman, PhD

Role: primary

Other Identifiers

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1R01DK134706-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-0545

Identifier Type: -

Identifier Source: org_study_id

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