Exercise Dose Response for Improving Insulin Sensitivity

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452035
• Other study ID #: R01 DK077966 - MX
• Secondary ID: R01DK077966
• Status: Completed
• Phase: N/A
• First received: October 11, 2011
• Last updated: November 7, 2016
• Start date: January 2009
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Obesity

Intervention

Other:
• Exercise
single session of exercise

Locations

Country	Name	City	State
United States	Michigan Clincal Research Unit	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2-3 hours	No
Secondary	Resting Metabolic Rate		40-60 min	No
Secondary	Meal Tolerance Test		2-3h	No