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Insulin ResistanceARTIISNCT01787617

Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men

A study testing Aerobic Plus Resistance Training Group in people with Insulin Resistance and Type 2 Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Insulin Resistance, Type 2 Diabetes
What is being tested?
Aerobic Plus Resistance Training Group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
1 siteUnited States
Study dates
Dec 2012to 31 Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

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.

Read the 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.

Being tested
Aerobic Plus Resistance Training Group, Control Group
Keywords
Exercise Training, Strength Training, African American Men, Insulin Resistance
Medical subject headings
Insulin Resistance, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic Plus Resistance Training GroupBehavioural

    Also called Exercise

    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 GroupBehavioural

    Also called Healthy Living

    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.

Study groups in NCT01787617
Study groupRoleWhat they receive
Control GroupPlacebo comparatorWe will randomly assign 52 individuals to a no exercise healthy living group.
Receives: Behavioral: Control Group
Aerobic Plus Resistance Training GroupExperimentalWe will randomly assign 52 individuals to an aerobic plus resistance training group.
Receives: Behavioral: Aerobic Plus Resistance Training Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, week 10, week 20

Secondary outcomes (8)

  1. Diastolic Blood Pressure

    Blood pressure was measured at rest using a standard mercury sphygmomanometer.

    Measured: 20 weeks

  2. Systolic Blood Pressure

    Blood pressure was measured at rest using a standard mercury sphygmomanometer.

    Measured: 20 weeks

  3. Body Composition

    Body composition was assessed using the General Electric (General Electric; Milwaukee, WI) Lunar i-Dual energy X-ray absorptiometry.

    Measured: 20 weeks

  4. Cardiorespiratory Fitness

    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.

    Measured: 20 weeks

  5. Muscular Strength

    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.

    Measured: 20 weeks

  6. Mood

    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.

    Measured: 20 weeks

  7. Mental Health

    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.

    Measured: 20 weeks

  8. Physical Health

    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.

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionJul 2015
  4. Study completion31 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01787617
Sponsor's protocol ID
PBRC 11038
Acronym
ARTIIS
Status last verified
Oct 2024
First submitted
5 Feb 2013
Last updated
31 Oct 2024
Data monitoring committee
No

Publications

  • 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.

    PubMed 25979318

  • 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.

    PubMed 31939911

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Plus Resistance Training Group in people with Insulin Resistance and Type 2 Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks. (time frame: Baseline, week 10, week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01787617, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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