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Exercise Training and Insulin Sensitivity

Primary Purpose

Obesity, Exercise

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: non-smokers, weight stable (<4 kg) within the last 6 months will be recruited for this study. sedentary (not engaged in planned physical activities and performing less than a total of 2 h of physical activity per week during the last 6 months) men and women whose BMI is classified as obese (>30 kg/m2). Exclusion Criteria: cardiovascular disease, uncontrolled hypertension (no beta blockers), smokers, pregnant, have any recent changes in hormonal birth control, or on any medications known to impact metabolism. All participants will be regular sleepers with a duration of 7-9 hours/night. Subjects with orthopedic limitations will not be included.

Sites / Locations

  • University of Misouri

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

All subjects will undergo exercise training for 4 wks. 45-60 min of exercise, 4 sessions/wk supervised, 1 session unsupervised. intensity 60% of VO2 max

Outcomes

Primary Outcome Measures

GLUT4 protein expression
protein expression
TB1CD4 protein expression
TB1CD4 protein expression

Secondary Outcome Measures

percent body fat
Body fat will be measured using DEXA pre and post training

Full Information

First Posted
June 16, 2023
Last Updated
August 28, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05930834
Brief Title
Exercise Training and Insulin Sensitivity
Official Title
Exercise Training and Adipose Tissue Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Regular exercise participation is known to reduce cardiometabolic disease risk but the impact that exercise training has on adipose tissue (AT) metabolism is poorly understood, particularly in humans. It is well established that exercise training improves whole-body glucose levels and increases insulin sensitivity, and this can occur within one or two weeks. These effects are usually due to adaptations in skeletal muscle, the tissue responsible for the majority of glucose disposal. However, many studies have now determined that exercise training also results in adaptations in AT that improve whole-body metabolic health by improving glucose uptake into the AT. Skeletal muscle is thought to account for approximately 75-85% of glucose uptake , and this process is impaired in .individuals who are insulin-resistant state. It is postulated that the increased level of adiposity that accompanies severe obesity would result in higher dependency on AT for glucose uptake as the AT would be a bigger "sink". Thus the role of AT in inducing whole body insulin resistance is still unclear, particularly in individuals with obesity. This study will examine the changes in AT glucose uptake before and after 4 weeks of exercise training in obese individuals and establish if there are sex differences.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
All subjects will undergo exercise training for 4 wks. 45-60 min of exercise, 4 sessions/wk supervised, 1 session unsupervised. intensity 60% of VO2 max
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
All subjects will undergo exercise training for 4 wks. 45-60 min of exercise, 4 sessions/wk supervised, 1 session unsupervised. intensity 60% of VO2 max
Primary Outcome Measure Information:
Title
GLUT4 protein expression
Description
protein expression
Time Frame
4 weeks
Title
TB1CD4 protein expression
Description
TB1CD4 protein expression
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
percent body fat
Description
Body fat will be measured using DEXA pre and post training
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: non-smokers, weight stable (<4 kg) within the last 6 months will be recruited for this study. sedentary (not engaged in planned physical activities and performing less than a total of 2 h of physical activity per week during the last 6 months) men and women whose BMI is classified as obese (>30 kg/m2). Exclusion Criteria: cardiovascular disease, uncontrolled hypertension (no beta blockers), smokers, pregnant, have any recent changes in hormonal birth control, or on any medications known to impact metabolism. All participants will be regular sleepers with a duration of 7-9 hours/night. Subjects with orthopedic limitations will not be included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Maloney, MS
Phone
989-954-3366
Email
amzdr@mail.missouri.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Kanaley, PhD
Phone
573-882-2519
Email
kanaleyj@missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Kanaley
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Misouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

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Exercise Training and Insulin Sensitivity

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