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Exercise Dose Response for Improving Insulin Sensitivity

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
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, fatty acid metabolism, exercise

Eligibility Criteria

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

Inclusion Criteria:

  • Body Mass Index [BMI] = 30-45 kg/m2, weight stable (± 5 lbs in the past month), fasting blood glucose concentration must be <125 mg/dl.

Exclusion Criteria:

  • pregnancy, evidence of cardiovascular or metabolic disease, taking medications know to influence metabolism.

Sites / Locations

  • Michigan Clincal Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Sedentary Control

Arm Description

Outcomes

Primary Outcome Measures

Insulin Sensitivity
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity and will be performed using a primed 2h insulin infusion at a rate of 100 mU/m2/min.

Secondary Outcome Measures

Resting Metabolic Rate
Meal Tolerance Test

Full Information

First Posted
October 11, 2011
Last Updated
November 7, 2016
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
NCT01452035
Brief Title
Exercise Dose Response for Improving Insulin Sensitivity
Official Title
Comparing the Effects Exercise Intensity and Energy Expended During a Single Exercise Session on Insulin Sensitivity and Fatty Acid Partitioning Within Skeletal Muscle the Next Day in Obese Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (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
Many of the beneficial metabolic effects of endurance exercise training are not due to adaptations to weeks, months, or even years of training, but rather much is due to the response to the most recent exercise session(s). Therefore, the investigators contend that lifestyle interventions for obese individuals should be tailored to optimize the metabolic effects of the most recent exercise session(s). But the "dose" of exercise necessary to evoke these beneficial responses is not known, and the mechanisms responsible for these improvements are poorly understood. The findings from these studies will: 1) establish the minimum "dose" of a single exercise session necessary to improve insulin sensitivity the next day in obese adults, 2) characterize the underlying metabolic factors responsible for the improvement in insulin sensitivity, and 3) assess the cumulative metabolic adaptations that occur over days, weeks, and months of a low-intensity/low-volume lifestyle exercise program. Findings from these studies will provide valuable information for the development of lifestyle programs aimed at maximizing the key metabolic health benefits of each exercise session in obese patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
insulin sensitivity, fatty acid metabolism, exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Title
Sedentary Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
single session of exercise
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity and will be performed using a primed 2h insulin infusion at a rate of 100 mU/m2/min.
Time Frame
2-3 hours
Secondary Outcome Measure Information:
Title
Resting Metabolic Rate
Time Frame
40-60 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, weight stable (± 5 lbs in the past month), fasting blood glucose concentration must be <125 mg/dl. Exclusion Criteria: pregnancy, evidence of cardiovascular or metabolic disease, taking medications know to influence metabolism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz, Ph.D.
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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Exercise Dose Response for Improving Insulin Sensitivity

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