NCT06129110

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
27mo left

Started Jan 2024

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jan 2024Sep 2028

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

4.5 years

First QC Date

November 8, 2023

Last Update Submit

May 13, 2026

Conditions

ObesityInsulin SensitivityMuscle WeaknessAdiposityInsulin Resistance

Keywords

IMATIntermuscular Adipose TissueWeight LossDiet

Outcome Measures

Primary Outcomes (5)

  • Insulin Sensitivity

    Participants will undergo a standard 3-hour hyperinsulinemic/euglycemic clamp with insulin infused at 80 mU/m2/min, and glucose clamped at 90 mg/dl with a variable dextrose infusion.

    12 weeks

  • Body Weight

    Participant weight will be measured using BodyTrace scales during the 12 week intervention.

    12 weeks

  • IMAT Content

    A multi-slice MRI will be used to quantify IMAT and muscle content in both legs with acquisition of \~20 axial images (10 mm thickness) with 10 mm spacing between images starting superior to the patella. IMAT content will be quantified using the well-validated Sirlin 6-echo method and normalized to muscle volume.

    12 weeks

  • Muscle Mass

    A multi-slice MRI will be used to quantify IMAT and muscle content in both legs with acquisition of \~20 axial images (10 mm thickness) with 10 mm spacing between images starting superior to the patella. Muscle volume will be quantified using standard methods with anatomical cross-sectional area evaluated in each T1 weighted, high resolution, gradient echo profile scan, and multiplied by the length of the muscle.

    12 weeks

  • Muscle Strength

    Participants will perform quadriceps muscle strength testing using an isokinetic dynamometer.

    12 weeks

Study Arms (2)

Diet Weight Loss

EXPERIMENTAL

Low calorie meal replacement shakes

Behavioral: Diet Weight Loss

Delayed Intervention

NO INTERVENTION

Normal feeding

Interventions

Diet Weight LossBEHAVIORAL

Low calorie diet of meal replacement shakes

Diet Weight Loss

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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:
  • Currently going through menopause or peri-menopause
  • Pregnant or breastfeeding
  • History of Polycystic Ovary Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

ObesityInsulin ResistanceMuscle WeaknessWeight Loss

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesBody Weight Changes

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Bryan Bergman, PhD

CONTACT

3037243919bryan.bergman@cuanschutz.edu

Sophia Bowen

CONTACT

3037240487sophia.bowen@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

January 31, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)