Aerobic Plus Resistance Training and Insulin Sensitivity (ARTIIS) in African American Men - Full Text View

Purpose

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.

Condition	Intervention
African American Men Prevention of Diabetes Type 2 Diabetes	Behavioral: Exercise-Aerobic Plus Resistance Training Group Behavioral: No Exercise-Healthy Living

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Exercise and Physical Fitness

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:

Change in insulin response to an oral glucose tolerance test over 5 months. [ Time Frame: 20-weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Homeostasis Model Assessment (HOMA) Method. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
This is another way of calculating insulin resistance.
Blood Pressure [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Exercise Training is monitored through the study and should result in lower blood pressure.
Dual Energy X-ray Absorptiometry (DEXA) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Fitness testing is being used as a measure of change in the aerobic component of the intervention.
Muscular Strength Testing [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Strength testing is performed in order to assess change in response to the resistance training program.
Psychosocial Measures and Mood [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The Health Related Quality of Life (SF-36) questionnaire is being used to assess perceived quality of life, which usually improves through regular exercise.

Estimated Enrollment:	104
Study Start Date:	December 2012
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Control Group We will randomly assign 52 individuals to a no exercise healthy living group.	Behavioral: No Exercise-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. Other Name: Control
Experimental: Aerobic Plus Resistance Training Group We will randomly assign 52 individuals to an aerobic plus resistance training group.	Behavioral: Exercise-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

Arms

Assigned Interventions

Placebo Comparator: Control Group

We will randomly assign 52 individuals to a no exercise healthy living group.

Behavioral: No Exercise-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.

Other Name: Control

Experimental: Aerobic Plus Resistance Training Group

We will randomly assign 52 individuals to an aerobic plus resistance training group.

Behavioral: Exercise-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

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.

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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/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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787617

Locations

United States, Louisiana
Pennington Biomedical Research Center	Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Robert Newton, Jr., PhD 225-763-3000 recruiters@pbrc.edu
Principal Investigator: Robert L. Newton, PhD
Sub-Investigator: Timothy Church, MD,MPH, PhD
Sub-Investigator: William Johnson, PhD

Sponsors and Collaborators

Pennington Biomedical Research Center

Investigators

Principal Investigator:

Robert L. Newton, PhD

Pennington Biomedical Research Center

More Information

No publications provided

Responsible Party:	Robert Newton, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT01787617 History of Changes
Other Study ID Numbers:	PBRC11038 ARTIIS
Study First Received:	February 5, 2013
Last Updated:	February 6, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:

Exercise Training
Strength Training
African American Men
Insulin Resistance

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013