Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men

Type 2 Diabetes Clinical Trial

— ARTIIS  

Official title:

Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01787617
• Other study ID #: PBRC 11038
• Status: Active, not recruiting
• Phase: N/A
• First received: February 5, 2013
• Last updated: May 2, 2016
• Start date: December 2012
• Est. completion date: March 2017

Study information

• Verified date: May 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: March 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20-weeks	No
Secondary	Homeostasis Model Assessment (HOMA) Method.	This is another way of calculating insulin resistance.	20 weeks	No
Secondary	Blood Pressure	Exercise Training is monitored through the study and should result in lower blood pressure.	20 weeks	No
Secondary	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.	20 weeks	No
Secondary	Cardiorespiratory Fitness Testing	Fitness testing is being used as a measure of change in the aerobic component of the intervention.	20 weeks	No
Secondary	Muscular Strength Testing	Strength testing is performed in order to assess change in response to the resistance training program.	20 weeks	No
Secondary	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.	20 weeks	No
Secondary	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.	20 weeks	No