Aerobic Plus Resistance Training and Insulin Sensitivity (ARTIIS) in African American Men

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Robert Newton, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01787617
First received: February 5, 2013
Last updated: August 8, 2014
Last verified: August 2014
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 8, 2014
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 August 18, 2014