Exercise Dose Response for Improving Insulin Sensitivity

November 7, 2016 updated by: Jeffrey F Horowitz, University of Michigan

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Clincal Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Other: Exercise
single session of exercise
No Intervention: Sedentary Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Sensitivity
Time Frame: 2-3 hours
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.
2-3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Resting Metabolic Rate
Time Frame: 40-60 min
40-60 min
Meal Tolerance Test
Time Frame: 2-3h
2-3h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

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

Investigators

  • Principal Investigator: Jeffrey F Horowitz, Ph.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01 DK077966 - MX
  • R01DK077966 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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