Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men (ARTIIS)
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|ClinicalTrials.gov Identifier: NCT01787617|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2013
Last Update Posted : May 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance Type 2 Diabetes||Behavioral: Aerobic Plus Resistance Training Group Behavioral: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||March 2017|
Placebo Comparator: Control Group
We will randomly assign 52 individuals to a no exercise healthy living group.
Behavioral: Control Group
Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
Other Name: Healthy Living
Experimental: Aerobic Plus Resistance Training Group
We will randomly assign 52 individuals to an aerobic plus resistance training group.
Behavioral: Aerobic Plus Resistance Training Group
Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
Other Name: Exercise
- Change in insulin response to an oral glucose tolerance test over 5 months. [ Time Frame: 20-weeks ]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. We will administer this test at Baseline, Week 10, and Week 20.
- Homeostasis Model Assessment (HOMA) Method. [ Time Frame: 20 weeks ]This is another way of calculating insulin resistance.
- Blood Pressure [ Time Frame: 20 weeks ]Exercise Training is monitored through the study and should result in lower blood pressure.
- Dual Energy X-ray Absorptiometry (DEXA) [ Time Frame: 20 weeks ]DEXA is being used as a measure of change in body fat and fat distribution, both of which should be altered through exercise training.
- Cardiorespiratory Fitness Testing [ Time Frame: 20 weeks ]Fitness testing is being used as a measure of change in the aerobic component of the intervention.
- Muscular Strength Testing [ Time Frame: 20 weeks ]Strength testing is performed in order to assess change in response to the resistance training program.
- Psychosocial Measures and Mood [ Time Frame: 20 weeks ]The Center for Epidemiology Studies Depression Scale (CES-D) is being used to assess depressive symptomatology that should be reduced during the program.
- Quality of Life Measures [ Time Frame: 20 weeks ]The Health Related Quality of Life (SF-36) questionnaire is being used to assess perceived quality of life, which usually improves through regular exercise.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787617
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Robert L. Newton, PhD||Pennington Biomedical Research Center|