NCT04532814

Brief Summary

The purpose of this study is to provide the first integrated examination of the interaction between muscle insulin action and exercise-stimulated muscle glucose uptake in obesity from the whole body to the cellular/molecular level.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress97%
Nov 2020Jul 2026

First Submitted

Initial submission to the registry

August 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 6, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

5.7 years

First QC Date

August 27, 2020

Last Update Submit

August 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Skeletal muscle glucose uptake

    Is exercise induced skeletal muscle glucose uptake different in obese compared to lean adults

    1 hour

Study Arms (2)

Lean

OTHER

Control

Other: Exercise

Obese

EXPERIMENTAL
Other: Exercise

Interventions

Cycling 60% VO2 max

LeanObese

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For the exercise studies of leg glucose uptake - "insulin sensitive" group:
  • Sedentary, normal weight, premenopausal women.
  • Sedentary, age-matched normal weight men.
  • Weight stable for two (2) months prior to study.
  • Willing to provide written, informed consent.
  • For the exercise studies of leg glucose uptake - "insulin resistant" group:
  • For the exercise studies of leg glucose uptake - "insulin resistant" group:
  • Upper body obese (UBO) premenopausal women.
  • Age-matched upper body obese (UBO) men.
  • Weight stable for two (2) months prior to study.
  • Willing to provide written, informed consent.

You may not qualify if:

  • Age \< 18 or \> 55 years (premenopausal women and age-matched men).
  • Use of glucose-lowering agents.
  • For female subjects: positive pregnancy test at the time of enrollment or study
  • History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
  • Active systemic illness or malignancy.
  • Symptomatic macrovascular or microvascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michael D Jensen, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This study is aimed to determine whether obesity effects muscle glucose utilization during exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2020

First Posted

August 31, 2020

Study Start

November 6, 2020

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations