Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men

NCT01787617 | Completed Results

• 1 other identifier: PBRC 11038
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Type 2 Diabetes

Keywords

Exercise Training; Strength Training; African American Men; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Response to an Oral Glucose Tolerance Test Over 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.

  Baseline, week 10, week 20

Secondary Outcomes (8)

• Diastolic Blood Pressure

  20 weeks

• Systolic Blood Pressure

  20 weeks

• Body Composition

  20 weeks

• Cardiorespiratory Fitness

  20 weeks

• Muscular Strength

  20 weeks

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Behavioral: Control Group

Aerobic Plus Resistance Training Group

EXPERIMENTAL

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

Behavioral: Aerobic Plus Resistance Training Group

Interventions

Aerobic Plus Resistance Training Group BEHAVIORAL

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.

Also known as: Exercise

Aerobic Plus Resistance Training Group

Control Group BEHAVIORAL

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.

Also known as: Healthy Living

Control Group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

• 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.

  PMID: 25979318 BACKGROUND

• 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.

  PMID: 31939911 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2

Interventions

Exercise; Control Groups

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. Robert Newton
• Organization: Pennington Biomedical Research Center

Robert.Newton@pbrc.edu

225-763-3034

Study Officials

• Robert L. Newton, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 8, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: March 31, 2018
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-10

Locations

US (1)