Clinical trial NCT01787617: Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men
Official title: Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Type 2 Diabetes
Keywords: Exercise Training
Strength Training
African American Men
Insulin Resistance
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 113
Sex: MALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks.
timeFrame: Baseline, week 10, week 20
Secondary outcomes:
measure: Diastolic Blood Pressure
timeFrame: 20 weeks
measure: Systolic Blood Pressure
timeFrame: 20 weeks
measure: Body Composition
timeFrame: 20 weeks
measure: Cardiorespiratory Fitness
timeFrame: 20 weeks
measure: Muscular Strength
timeFrame: 20 weeks
measure: Mood
timeFrame: 20 weeks
measure: Mental Health
timeFrame: 20 weeks
measure: Physical Health
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Robert L. Newton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newton RL Jr, Johnson WD, Hendrick C, Harris M, Andrews E 3rd, Johannsen N, Rodarte RQ, Hsia DS, Church TS. A randomized controlled exercise training trial on insulin sensitivity in African American men: The ARTIIS study: Major category: study design, statistical design, study protocols. Contemp Clin Trials. 2015 Jul;43:75-82. doi: 10.1016/j.cct.2015.05.004. Epub 2015 May 12.
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.