This trial is active, not recruiting.

Conditions insulin resistance, type 2 diabetes
Treatments aerobic plus resistance training group, control group
Sponsor Pennington Biomedical Research Center
Start date December 2012
End date July 2015
Trial size 113 participants
Trial identifier NCT01787617, PBRC 11038


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
(Placebo Comparator)
We will randomly assign 52 individuals to a no exercise healthy living group.
control group Healthy Living
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.
We will randomly assign 52 individuals to an aerobic plus resistance training group.
aerobic plus resistance training group Exercise
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.

Primary Outcomes

Change in insulin response to an oral glucose tolerance test over 5 months.
time frame: 20-weeks

Secondary Outcomes

Homeostasis Model Assessment (HOMA) Method.
time frame: 20 weeks
Blood Pressure
time frame: 20 weeks
Dual Energy X-ray Absorptiometry (DEXA)
time frame: 20 weeks
Cardiorespiratory Fitness Testing
time frame: 20 weeks
Muscular Strength Testing
time frame: 20 weeks
Psychosocial Measures and Mood
time frame: 20 weeks
Quality of Life Measures
time frame: 20 weeks

Eligibility Criteria

Male participants from 35 years up to 70 years old.

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/m2. - 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 - Have had cancer requiring treatment in the past 5 years, expect for non-melanoma skin cancers or cancers that have clearly been cured or in the option of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer) - Have autoimmune or collagen vascular diseases - Have immunodeficiency diseases or HIV - You have any other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator are life-threatening or that may interfere with study participation or the ability to follow the intervention protocol.

Additional Information

Official title Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men
Principal investigator Robert L. Newton, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Pennington Biomedical Research Center.