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

Primary Purpose

Insulin Resistance, Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Plus Resistance Training Group
Control Group
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring Exercise Training, Strength Training, African American Men, Insulin Resistance

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Aerobic Plus Resistance Training Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in insulin response to an oral glucose tolerance test over 5 months.
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.
This is another way of calculating insulin resistance.
Blood Pressure
Exercise Training is monitored through the study and should result in lower blood pressure.
Dual Energy X-ray Absorptiometry (DEXA)
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
Fitness testing is being used as a measure of change in the aerobic component of the intervention.
Muscular Strength Testing
Strength testing is performed in order to assess change in response to the resistance training program.
Psychosocial Measures and Mood
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
The Health Related Quality of Life (SF-36) questionnaire is being used to assess perceived quality of life, which usually improves through regular exercise.

Full Information

First Posted
February 5, 2013
Last Updated
May 2, 2016
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01787617
Brief Title
Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men
Acronym
ARTIIS
Official Title
Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Type 2 Diabetes
Keywords
Exercise Training, Strength Training, African American Men, Insulin Resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
We will randomly assign 52 individuals to a no exercise healthy living group.
Arm Title
Aerobic Plus Resistance Training Group
Arm Type
Experimental
Arm Description
We will randomly assign 52 individuals to an aerobic plus resistance training group.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Plus Resistance Training Group
Other Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Other Intervention Name(s)
Healthy Living
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in insulin response to an oral glucose tolerance test over 5 months.
Description
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.
Time Frame
20-weeks
Secondary Outcome Measure Information:
Title
Homeostasis Model Assessment (HOMA) Method.
Description
This is another way of calculating insulin resistance.
Time Frame
20 weeks
Title
Blood Pressure
Description
Exercise Training is monitored through the study and should result in lower blood pressure.
Time Frame
20 weeks
Title
Dual Energy X-ray Absorptiometry (DEXA)
Description
DEXA is being used as a measure of change in body fat and fat distribution, both of which should be altered through exercise training.
Time Frame
20 weeks
Title
Cardiorespiratory Fitness Testing
Description
Fitness testing is being used as a measure of change in the aerobic component of the intervention.
Time Frame
20 weeks
Title
Muscular Strength Testing
Description
Strength testing is performed in order to assess change in response to the resistance training program.
Time Frame
20 weeks
Title
Psychosocial Measures and Mood
Description
The Center for Epidemiology Studies Depression Scale (CES-D) is being used to assess depressive symptomatology that should be reduced during the program.
Time Frame
20 weeks
Title
Quality of Life Measures
Description
The Health Related Quality of Life (SF-36) questionnaire is being used to assess perceived quality of life, which usually improves through regular exercise.
Time Frame
20 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Newton, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31939911
Citation
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.
Results Reference
derived

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Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men

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