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Clinical Trials/NCT01787617
NCT01787617
Completed
Not Applicable

Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men

Pennington Biomedical Research Center1 site in 1 country113 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insulin Resistance
Sponsor
Pennington Biomedical Research Center
Enrollment
113
Locations
1
Primary Endpoint
Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks.
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to investigate the effect of an exercise training intervention on the ability of African American males to use insulin properly. Insulin is a hormone that helps the body use glucose.

Detailed Description

This study is designed to assess the effect of exercise training on insulin resistance in African American males. African American males have higher rates of diabetes and lower levels of fitness when compared to Caucasian males. A project such as this is necessary because there is evidence to show that exercise training can reduce the risk of developing diabetes, though no studies have been conducted in African American males. In addition, ARTIIS will test the effect adhering to the 2008 Physical Activity Guidelines for Americans (150 minutes of moderate intensity aerobic activity and 2 days of 20 minutes of muscular strength activity), on insulin resistance in African American men. This study will provide important information that can either strengthen or refine current physical activity recommendations. Furthermore, this intervention will be delivered through community facilities in order to increase the likelihood that the intervention will be sustainable.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
March 31, 2018
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert L. Newton, Jr.

Associate Professor

Pennington Biomedical Research Center

Eligibility Criteria

Inclusion Criteria

  • You completed the three run-in screening visits.
  • You self-identify as a male of African descent.
  • You are 35 to 70 years of age.
  • You have a BMI (ratio of your height to your weight) greater than or equal to 25.0 kg/m2 and less than or equal to 40 kg/m
  • You have a family history of diabetes.
  • You are not currently physically active for 20 minutes each time for 3 or more days per week for the last 6 months. You are not participating in regular muscle building exercise.
  • You are willing to give informed consent, willing to be randomized to either the healthy living intervention group or the aerobic plus resistance training exercise group, and willing to follow the protocol for the group to which you have been assigned.

Exclusion Criteria

  • You drink more than 14 alcoholic drinks per week.
  • You plan to move out of the study area within the next 6 months, or plan to be out of the study area for more than 4 weeks during the course of the study.
  • You have another member of your household participating in the study.
  • You have serious health conditions that would interfere with the intervention goals
  • History of cardiovascular disease (CVD) or disorders and are not under the care of a physician to treat the condition, or fail to provide written documentation from your physician indicating that the physician approves of your entering the study
  • Have high blood pressure (greater than 155/99 mmHg) and are not under the care of a physician to treat the condition or fail to provide written documentation from your physician indicating that the physician approves of your entering the study
  • Have a previous diagnosis of diabetes (Type 1 or 2) or a fasting plasma glucose of \>125 mg/dl
  • Have elevated bad cholesterol (greater than or equal to 190mg/dl) or triglycerides (great than or equal to 300) and are not under the care of a physician to treat the condition or fail to provide written documentation from your physician indicating that the physician approves of you entering the study
  • Are currently taking medications for diabetes or chronic steroid use
  • Have chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological or psychiatric conditions

Outcomes

Primary Outcomes

Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks.

Time Frame: Baseline, week 10, week 20

An oral glucose tolerance test is a medical test in which glucose is given and blood samples are taken afterward to determine how quickly it is cleared from the blood. The test is usually used to test for diabetes or insulin resistance.

Secondary Outcomes

  • Diastolic Blood Pressure(20 weeks)
  • Systolic Blood Pressure(20 weeks)
  • Body Composition(20 weeks)
  • Cardiorespiratory Fitness(20 weeks)
  • Muscular Strength(20 weeks)
  • Mood(20 weeks)
  • Mental Health(20 weeks)
  • Physical Health(20 weeks)

Study Sites (1)

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