Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity

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.

Study Overview

• Status: Recruiting
• Conditions: Upper Body Obesity
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pamela Reich; Phone Number: 507-255-6062; Email: Reich.Pamela@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Michael D Jensen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lean; Control	Other: Exercise; Cycling 60% VO2 max
Experimental: Obese	Other: Exercise; Cycling 60% VO2 max

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle glucose uptake	Is exercise induced skeletal muscle glucose uptake different in obese compared to lean adults	1 hour

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Michael D Jensen, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 20-002949; R01DK045343 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No