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Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise - caloric balance
No Exercise - hyper-caloric diet
No exercise - caloric balance
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 exercise, fatty acid metabolism, insulin sensitivity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Premenopausal; Body mass index 30-40 kg/m2; Waist circumference >88 cm

Exclusion Criteria:

  • Evidence of metabolic or cardiovascular disease; Pregnancy; Hyperlipidemia (fasting plasma triglyceride concentration > 150 mg/dl); Hematocrit < 34%; Undertaking regular exercise (i.e., >2 times/week)

Sites / Locations

  • Michigan Clincal Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise

Sedentary Control

Arm Description

90 min exercise on Day 1

Subjects remain sedentary on Day 1 and will either consume a hyper-caloric or a caloric balanced diet

Outcomes

Primary Outcome Measures

Insulin Sensitivity
frequently sampled intravenous glucose tolerance test(FSIVGTT)will be done to assess insuiln sensitivity

Secondary Outcome Measures

Full Information

First Posted
October 11, 2011
Last Updated
November 22, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01451957
Brief Title
Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity
Official Title
Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible for the improvements in metabolic health after a single session of endurance exercise. The investigators will determine the effect of a single session of endurance exercise on whole-body fatty acid mobilization and oxidation, IMTG concentration and the expression of factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity (age: 18-45y). In addition, the investigators will evaluate how these factors, and exercise, effect insulin signalling and insulin sensitivity. Every effort will be made to recruit subjects from ethnic and minority groups. Before participating in the study, subjects will be informed of all the procedures and potential risks, and they will sign an informed consent form approved by The University of Michigan Institutional Review Board. Eligible volunteers will participate in three separate trials, in a randomized order. In two trials subjects will eat exactly the same amount of calories, except in one trial they will exercise (eucaloric + exercise) and in the other trial they will remain sedentary (hypercaloric). In a third trial subjects will again remain sedentary but instead they will ingest appropriate calories to maintain caloric balance (eucaloric + sedentary). By doing this the investigators are also able to investigate the effect of acute caloric perturbations on insulin sensitivity, because it is possible that the enhanced insulin sensitivity evident after exercise, as compared to the sedentary state, is due to caloric deficit and not the exercise bout, per se.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
90 min exercise on Day 1
Arm Title
Sedentary Control
Arm Type
Experimental
Arm Description
Subjects remain sedentary on Day 1 and will either consume a hyper-caloric or a caloric balanced diet
Intervention Type
Other
Intervention Name(s)
Exercise - caloric balance
Intervention Description
90 min exercise on Day 1 with meals afterward resulting in caloric balance for the day (i.e.; extra kcals provided to account for energy expended during exercise)]
Intervention Type
Other
Intervention Name(s)
No Exercise - hyper-caloric diet
Intervention Description
Subjects remain sedentary on Day 1 and they ingest meals that are identical to those ingested on the day they performed exercise (i.e.; more calories ingested than expended because no exercise performed).
Intervention Type
Other
Intervention Name(s)
No exercise - caloric balance
Intervention Description
Subjects remain sedentary on Day 1 and they ingest a similar proportion of macronutrients however, the total calories ingested will be lower than the other two trials, resulting in caloric balance for the day.
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
frequently sampled intravenous glucose tolerance test(FSIVGTT)will be done to assess insuiln sensitivity
Time Frame
3 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Premenopausal; Body mass index 30-40 kg/m2; Waist circumference >88 cm Exclusion Criteria: Evidence of metabolic or cardiovascular disease; Pregnancy; Hyperlipidemia (fasting plasma triglyceride concentration > 150 mg/dl); Hematocrit < 34%; Undertaking regular exercise (i.e., >2 times/week)
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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Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity

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