N/A
N=113
Aerobic Plus Resistance Training and Insulin Sensitivity in African American Men
Insulin Resistance · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01787617 ↗Enrolled (actual)
113
Serious AEs
0.9%
Results posted
Oct 2024
Primary outcome: Primary: Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks. — 110.51; 106.64; 90.68; 80.23 uU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aerobic Plus Resistance Training Group (Behavioral); Control Group (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Male
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Response to an Oral Glucose Tolerance Test Over 20 Weeks. |
110.51; 106.64; 90.68; 80.23; 86.7; 80.74 | — |
| SECONDARY Diastolic Blood Pressure |
81.2; 81.74; 72.13; 70.8; 79.16; 79.85 | — |
| SECONDARY Systolic Blood Pressure |
123.04; 124.39; 116.13; 114.84; 120.06; 122.68 | — |
| SECONDARY Body Composition |
100.79; 99.75; 99.46; 97.97 | — |
| SECONDARY Cardiorespiratory Fitness |
2.41; 2.41; 2.3; 2.6 | — |
| SECONDARY Muscular Strength |
3926.1; 4011.0; 3999.5; 4113.7 | — |
| SECONDARY Mood |
5.75; 6.05; 10.09; 10.37 | — |
| SECONDARY Mental Health |
56.59; 55.53; 57.27; 54.41 | — |
| SECONDARY Physical Health |
55.84; 55.35; 54.96; 53.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01787617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.