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CompletedNCT01787617ARTIISUpdated Oct 31, 2024Results posted

Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men

An interventional study of Aerobic Plus Resistance Training Group and Control Group in Insulin Resistance and Type 2 Diabetes, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to male participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
35 Years to 70 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Insulin Resistance
  • Type 2 Diabetes

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Keywords

  • Exercise Training
  • Strength Training
  • African American Men
  • Insulin Resistance
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 113 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
113 participants (actual)

Study arms

  • Placebo comparator
    Control Group

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

    Behavioral: Control Group

  • Experimental
    Aerobic Plus Resistance Training Group

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

    Behavioral: Aerobic Plus Resistance Training Group

Interventions

  • BehavioralAerobic 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.

    Also known as: Exercise

  • BehavioralControl 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.

    Also known as: Healthy Living

06

What researchers measure

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.

    Time frame: Baseline, week 10, week 20

Secondary outcomes

  1. Diastolic Blood Pressure

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

    Time frame: 20 weeks

  2. Systolic Blood Pressure

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

    Time frame: 20 weeks

  3. Body Composition

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 20 weeks

07

Results

Posted Oct 31, 2024

Participant flow

Participant flow — Overall Study
MilestoneControl GroupAerobic Plus Resistance Training Group
Started5657
Completed5451
Not completed26

Outcome measures

PrimaryInsulin 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.

Time frame:
Baseline, week 10, week 20
Reported as:
Mean · uU/mL
Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks.
uU/mLControl GroupAerobic Plus Resistance Training Group
Baseline110.51 ± 8.14106.64 ± 7.77
Week 1090.68 ± 8.1380.23 ± 6.52
Week 2086.7 ± 7.380.74 ± 7.25
SecondaryDiastolic Blood Pressure

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

Time frame:
20 weeks
Reported as:
Mean · mmHg
Diastolic Blood Pressure
mmHgControl GroupAerobic Plus Resistance Training Group
Baseline81.2 ± 1.0481.74 ± 1.16
Week 1072.13 ± 1.0470.8 ± 1.06
Week 2079.16 ± 1.0979.85 ± 1.27
SecondarySystolic Blood Pressure

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

Time frame:
20 weeks
Reported as:
Mean · mm Hg
Systolic Blood Pressure
mm HgControl GroupAerobic Plus Resistance Training Group
Baseline123.04 ± 1.5124.39 ± 1.62
Week 10116.13 ± 1.53114.84 ± 1.64
Week 20120.06 ± 1.6122.68 ± 1.76
SecondaryBody Composition

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

Time frame:
20 weeks
Reported as:
Mean · kg
Body Composition
kgControl GroupAerobic Plus Resistance Training Group
Baseline100.79 ± 2.5499.75 ± 2.25
Week 2099.46 ± 2.8297.97 ± 2.39
SecondaryCardiorespiratory 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.

Time frame:
20 weeks
Reported as:
Mean · L/min of oxygen
Cardiorespiratory Fitness
L/min of oxygenControl GroupAerobic Plus Resistance Training Group
Baseline2.41 ± 0.072.41 ± 0.07
Week 202.3 ± 0.092.6 ± 0.09
SecondaryMuscular 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.

Time frame:
20 weeks
Reported as:
Mean · Joules
Muscular Strength
JoulesControl GroupAerobic Plus Resistance Training Group
Baseline3926.1 ± 788.24011.0 ± 833.2
Week 203999.5 ± 984.34113.7 ± 972.3
SecondaryMood

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.

Time frame:
20 weeks
Reported as:
Mean · score on a scale
Mood
score on a scaleControl GroupAerobic Plus Resistance Training Group
Baseline5.75 ± 0.596.05 ± 0.66
Week 2010.09 ± 0.9910.37 ± 1.04
SecondaryMental 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.

Time frame:
20 weeks
Reported as:
Mean · T-score
Mental Health
T-scoreControl GroupAerobic Plus Resistance Training Group
Baseline56.59 ± 0.8555.53 ± 0.89
Week 2057.27 ± 0.7154.41 ± 1.21
SecondaryPhysical 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.

Time frame:
20 weeks
Reported as:
Mean · T-score
Physical Health
T-scoreControl GroupAerobic Plus Resistance Training Group
Baseline55.84 ± 0.5155.35 ± 0.8
Week 2054.96 ± 0.7953.4 ± 1.11

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healthy Living Control—0/56 (0%)4/56 (7.1%)
Aerobic Plus Resistance Training Group—1/57 (1.8%)16/57 (28.1%)
Most frequent serious events
Most frequent serious events
EventHealthy Living ControlAerobic Plus Resistance Training Group
IllnessSkin and subcutaneous tissue disorders0/561/57
Most frequent other events
Showing 10 of 20
Most frequent other events
EventHealthy Living ControlAerobic Plus Resistance Training Group
Muscle/Joint/InjuryMusculoskeletal and connective tissue disorders1/560/57
Muscle/Joint/InjuryMusculoskeletal and connective tissue disorders1/560/57
Abnormal lab valuesGeneral disorders1/560/57
Muscle/Joint/InjuryHepatobiliary disorders1/560/57
Muscle/Joint/InjuryRenal and urinary disorders0/561/57
Muscle/Joint/InjuryRenal and urinary disorders0/561/57
Muscle/Joint/InjuryMusculoskeletal and connective tissue disorders0/561/57
Surgery/hospitalizationMusculoskeletal and connective tissue disorders0/561/57
Muscle/Joint/InjuryMusculoskeletal and connective tissue disorders0/561/57
Muscle/Joint/InjuryMusculoskeletal and connective tissue disorders0/561/57

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Control GroupAerobic Plus Resistance Training GroupTotal
<=18 years000
Between 18 and 65 years5155106
>=65 years527
Age, Continuous
Age, Continuous(Years)Control GroupAerobic Plus Resistance Training GroupTotal
Mean53.6 ± 8.1350.54 ± 9.5951.99 ± 8.97
Sex: Female, Male
Sex: Female, Male(Participants)Control GroupAerobic Plus Resistance Training GroupTotal
Female000
Male5657113
Region of Enrollment
Region of Enrollment(participants)Control GroupAerobic Plus Resistance Training GroupTotal
United States5657113
08

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01787617
Lead sponsor
Pennington Biomedical Research Center
Responsible party
Robert L. Newton, Jr. (Associate Professor, Pennington Biomedical Research Center) — Principal investigator
First posted
Feb 8, 2013
Start date
Dec 2012
Primary completion
Jul 2015
Completion
Mar 31, 2018
Results posted
Oct 31, 2024
Last update
Oct 31, 2024

Study contacts

Robert L. Newton, PhD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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