Effect of Exercise on Metabolic Health

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02001142
• Collaborator: American Diabetes Association (Other)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 34.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

One of the main objectives of this study will be to assess potential differences in important risk factors associated with Metabolic Syndrome in overweight adults who do not participate in a regular exercise program compared with overweight individuals who do exercise regularly. In addition, we will determine the effects of a single, modest session of exercise on the body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults vs. obese adults who live a physically active lifestyle. Our study focuses on identifying mechanisms responsible for improved insulin action related to regular exercise and to provide novel targets for preventing and treating type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Exercise	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effect of Exercise on Novel Insulin Signaling Events in Human Muscle
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Sep 17, 2016
• Actual Study Completion Date: Sep 17, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Insulin Sensitivity [2-3 hours]

   A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity. Insulin sensitivity will be calculated from the clamp data as the rate of glucose infusion during the steady state period of the clamp - divided by the plasma insulin concentration at this time (units: mg/uU/ml/min)

Secondary Outcome Measures

1. Resting Metabolic Rate [20-30 min]

2. Meal Tolerance Test [3 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Body Mass Index [BMI] = 30-45 kg/m2, fasting blood glucose concentration must be < or = to125 mg/dl, Hematocrit > or = to 34%, all women must be pre-menopausal

Exclusion Criteria:

• pregnancy or actively breastfeeding, weight instability (> or = to ± 5 lbs in the past month) evidence of cardiovascular or metabolic diseases, taking medications know to affect lipid and/or glucose metabolism.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michigan Clincal Research Unit	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• American Diabetes Association

Investigators

• Principal Investigator: Jeffrey F Horowitz, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeffrey F Horowitz, Associate Professor, Movement Science, School of Kinesiology, University of Michigan
• ClinicalTrials.gov Identifier: NCT02001142
• Other Study ID Numbers: ADA 7-13-TS-35
• First Posted: Dec 4, 2013
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Jeffrey F Horowitz, Associate Professor, Movement Science, School of Kinesiology, University of Michigan: Insulin Sensitivity; Exercise; Metabolism

Study Results

No Results Posted as of Mar 21, 2022