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

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ClinicalTrials.gov Identifier: NCT01787617
Recruitment Status : Unknown
Verified May 2016 by Robert Newton, Pennington Biomedical Research Center.
Recruitment status was:  Active, not recruiting
First Posted : February 8, 2013
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Newton, Pennington Biomedical Research Center

Tracking Information
First Submitted Date  ICMJE February 5, 2013
First Posted Date  ICMJE February 8, 2013
Last Update Posted Date May 3, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men
Official Title  ICMJE Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Insulin Resistance
  • Type 2 Diabetes
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Control Group
    We will randomly assign 52 individuals to a no exercise healthy living group.
    Intervention: Behavioral: Control Group
  • Experimental: Aerobic Plus Resistance Training Group
    We will randomly assign 52 individuals to an aerobic plus resistance training group.
    Intervention: Behavioral: Aerobic Plus Resistance Training Group
Publications * Newton RL Jr, Johnson WD, Larrivee S, Hendrick C, Harris M, Johannsen NM, Swift DL, Hsia DS, Church TS. A Randomized Community-based Exercise Training Trial in African American Men: Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men. Med Sci Sports Exerc. 2020 Feb;52(2):408-416. doi: 10.1249/MSS.0000000000002149.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: May 12, 2015)
113
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2013)
104
Estimated Study Completion Date  ICMJE March 2017
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01787617
Other Study ID Numbers  ICMJE PBRC 11038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Newton, Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert L. Newton, PhD Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP