Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men

Not Applicable

Completed

• Conditions: Insulin Resistance; Type 2 Diabetes
• Interventions: Behavioral: Control Group; Behavioral: Aerobic Plus Resistance Training Group

• Registration Number: NCT01787617
• Lead Sponsor: Pennington Biomedical Research Center

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Primary Completion: 2015-07
• Study Completion: 2018-03-31
• Results First Submitted: 2023-02-28
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Results First Posted: 2024-10-31
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 113

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	We will randomly assign 52 individuals to a no exercise healthy living group.
Aerobic Plus Resistance Training Group	Aerobic Plus Resistance Training Group	We will randomly assign 52 individuals to an aerobic plus resistance training group.

Primary Outcome Measures

Name	Time	Method
Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks.	Baseline, week 10, week 20	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.

Secondary Outcome Measures

Name	Time	Method
Diastolic Blood Pressure	20 weeks	Blood pressure was measured at rest using a standard mercury sphygmomanometer.
Systolic Blood Pressure	20 weeks	Blood pressure was measured at rest using a standard mercury sphygmomanometer.
Body Composition	20 weeks	Body composition was assessed using the General Electric (General Electric; Milwaukee, WI) Lunar i-Dual energy X-ray absorptiometry.
Cardiorespiratory Fitness	20 weeks	Fitness testing is being used as a measure of change in the aerobic component of the intervention. Cardiorespiratory fitness maximal exercise tests were conducted using a standardized graded exercise testing protocol administered on a treadmill.
Muscular Strength	20 weeks	Strength testing is performed in order to assess change in response to the resistance training program. Muscular strength is measured via isokinetic testing on a Biodex System 4 Isokinetic Dynamometer.
Mood	20 weeks	Depressive symptomatology is measured by the Center for Epidemiology Studies Depression Scale (CES-D). The total score range is 0 to 60. Higher scores represent higher levels of depressive symptomatology.
Mental Health	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. The measure is scored on a T-scale, with a mean of 50 and standard deviation of 10. Higher scores represent better functioning. Scores below 40 suggest poorer functioning than normal, and scores above 60 represent better functioning than normal.
Physical Health	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. The measure is scored on a T-scale, with a mean of 50 and standard deviation of 10. Higher scores represent better functioning. Scores below 40 suggest poorer functioning than normal, and scores above 60 represent better functioning than normal.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States