NCT05328570

Brief Summary

Assess differences in structure and biological function of abdominal subcutaneous adipose tissue samples collected from adults who exercise regularly vs. a well-matched cohort of non-exercisers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 4, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2024

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

3.2 years

First QC Date

April 7, 2022

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Blood Glucose Level

    mg/dL

    2 hours at Experimental Trial

  • Adipose tissue fibrosis

    Pico-sirius Red stain (percent stained)

    baseline

Study Arms (1)

Oral Glucose Tolerance Test

EXPERIMENTAL

Subjects will complete an Oral Glucose Tolerance Test in which glucose is given and blood samples are taken every 15 minutes over a 2 hour period to determine how quickly the glucose is cleared from the blood.

Diagnostic Test: Oral Glucose Tolerance Test

Interventions

Subjects will complete an Oral Glucose Tolerance Test in which glucose is given and blood samples are taken every 15 minutes over a 2 hour period to determine how quickly the glucose is cleared from the blood.

Oral Glucose Tolerance Test

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-40 years old
  • Body Mass Index: 23-35 kg/m2
  • Women must have regularly occurring menses and must be premenopausal

You may not qualify if:

  • Evidence/history of cardiovascular or metabolic disease
  • Medications known to affect lipid or glucose metabolism, or inflammation
  • Weight instability ≥ ± 6 pounds in the last 6 months
  • Tobacco or e-cigarette users
  • Women must not be pregnant or actively lactating
  • Blood pressure \> 140/90 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Jeffrey F Horowitz, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Movement Science and Director of the Substrate Metabolism Laboratory (SML) at the University of Michigan School of Kinesiology

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

June 4, 2020

Primary Completion

August 3, 2023

Study Completion

December 9, 2024

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations