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Progressive Metabolic Adaptations to Low Intensity Exercise Training and Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Training
Weight Loss with continued Exercise Training
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Insulin Sensitivity, Exercise Training, Weight Loss, Fat Metabolism

Eligibility Criteria

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

Inclusion Criteria:

  • body mass index [BMI]: 30-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)

Exclusion Criteria:

  • Hematocrit ≤ 34%; Fasting plasma glucose concentration ≥ 125 mg/dL; Weight instability ≥ ±5 lbs in past month; Taking medications known to affect lipid and/or glucose metabolism; evidence and/or history of cardiovascular or frank metabolic diseases; pregnancy or actively breast feeding

Sites / Locations

  • Michigan Clincal Research Unit

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise Training with Weight Loss

Arm Description

During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight

Outcomes

Primary Outcome Measures

Insulin Sensitivity
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity

Secondary Outcome Measures

Resting Metabolic Rate
Meal Tolerance Test

Full Information

First Posted
October 11, 2011
Last Updated
March 18, 2022
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01452074
Brief Title
Progressive Metabolic Adaptations to Low Intensity Exercise Training and Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 18, 2014 (Actual)
Study Completion Date
July 18, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
the investigators first aim is to determine the effect of low intensity exercise (without weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days without exercise in obese adults. the investigators second aim is to determine the effect of combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle. Although a single 40 minute session of exercise at a low exercise intensity will not improve insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training program (without weight-loss) will be similar to that measured after 2 weeks of training. the investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and pro-inflammatory activation will be markedly improved after 10% weight loss when measured the day after exercise. the investigators would expect the improvements in Insulin sensitivity, accumulation of fatty acid intermediates, and markers of inflammatory stress will be significantly attenuated when measured 3 days after the most recent exercise session, but beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared with before weight loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Insulin Sensitivity, Exercise Training, Weight Loss, Fat Metabolism

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
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Training with Weight Loss
Arm Type
Other
Arm Description
During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week
Intervention Type
Other
Intervention Name(s)
Weight Loss with continued Exercise Training
Intervention Description
After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity
Time Frame
2-3 hours
Secondary Outcome Measure Information:
Title
Resting Metabolic Rate
Time Frame
20-30 min
Title
Meal Tolerance Test
Time Frame
2-3h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: body mass index [BMI]: 30-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity) Exclusion Criteria: Hematocrit ≤ 34%; Fasting plasma glucose concentration ≥ 125 mg/dL; Weight instability ≥ ±5 lbs in past month; Taking medications known to affect lipid and/or glucose metabolism; evidence and/or history of cardiovascular or frank metabolic diseases; pregnancy or actively breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Clincal Research Unit
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Progressive Metabolic Adaptations to Low Intensity Exercise Training and Weight Loss

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