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Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity

Primary Purpose

Upper Body Obesity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional basic science trial for Upper Body Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Lean

Obese

Arm Description

Control

Outcomes

Primary Outcome Measures

Skeletal muscle glucose uptake

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04532814

First Posted

August 27, 2020

Last Updated

March 10, 2023

Sponsor

Mayo Clinic

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04532814

Brief Title

Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity

Official Title

Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 6, 2020 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Body Obesity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study is aimed to determine whether obesity effects muscle glucose utilization during exercise.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lean

Arm Type

Other

Arm Description

Control

Arm Title

Obese

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

Cycling 60% VO2 max

Primary Outcome Measure Information:

Title

Skeletal muscle glucose uptake

Description

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

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pamela Reich

Phone

507-255-6062

reich.Pamela@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael D Jensen, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael D Jensen

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Exercise-stimulated Muscle Glucose Uptake in Upper Body Obesity

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