N/A
N=52
Effects of Exercise Training Intensity on Fitness and Insulin Sensitivity in African Americans
Obesity · Insulin Resistance · Sedentary Lifestyle
Bottom Line
View on ClinicalTrials.gov: NCT02892331 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Cardiorespiratory Fitness — -0.15; 0.12; 0.22 Liters of oxygen/min — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Moderate intensity exercise training (MOD-INT) (Behavioral); High Intensity exercise training (HI-INT) (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- East Carolina University
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cardiorespiratory Fitness |
-0.15; 0.12; 0.22 | 0.006 sig |
| SECONDARY Change in Body Fat Percentage |
0.09; -0.26; -0.71 | 0.276 |
| SECONDARY Change in Body Weight |
0.87; -0.37; -0.42 | 0.370 |
| SECONDARY Change in Waist Circumference |
-1.42; 0.41; -1.3 | 0.932 |
| SECONDARY Change in Low Density Lipoprotein |
-7.1; -0.12; 2.3 | 0.136 |
| SECONDARY Change in High Density Lipoprotein |
-3.4; -1.1; 1.3 | 0.056 |
| SECONDARY Changes in Total Cholesterol |
-10.4; -0.21; -0.71 | 0.224 |
| SECONDARY Change in Triglycerides |
-10.9; 4.0; -13.3 | 0.783 |
| SECONDARY Change in Systemic Inflammation |
0.142; 0.159; 0.31 | 0.940 |
| SECONDARY Change in Fasting Glucose |
-2.81; -2.5; -2.0 | 0.769 |
| SECONDARY Change in Insulin |
-2.68; -2.69; -2.7 | 1.000 |
| SECONDARY Change in Insulin Sensitivity |
0.60; 0.59; 0.44 | 0.821 |
| SECONDARY Change in Arterial Stiffness |
-0.21; 0.68; 0.47 | 0.093 |
| SECONDARY Change in Mitochondrial Enzymes |
-0.17; 0.02; -0.02; -0.01; 0.02; 0.17 | 0.424 |
| SECONDARY Change in Quality of Life |
-1.6; 1.3; -1.0; -0.18; 0.57; 2.4 | 0.756 |
| SECONDARY Change in Quality of Life (Mental Health and Physical Health Summary Scores) |
0.75; -2.7; 1.6; -2.02; 0.02; -0.11 | 0.650 |
| SECONDARY Changes in Physical Activity Levels |
604.2; 2311.0; 2242.3 | 0.109 |
| SECONDARY Change in Dietary Composition |
— | — |
Summary
African Americans are at a substantially greater type 2 diabetes risk compared to Caucasians; however, very little data are available on the effects of exercise training on type 2 diabetes risk factors in at risk African Americans. The present proposal will evaluate the effects of 6 months of moderate versus vigorous intensity aerobic exercise training on fitness, insulin sensitivity, mitochondrial capacity, skeletal muscle oxidative/insulin sensitivity markers, adiposity, and quality of life in African Americans.
Eligibility Criteria
Inclusion Criteria
- African American
- Body mass index 30-45 kg/m2
- sedentary/low active (step count ≤ 6, 500 step/day)
- capable and willing to give written informed consent and understand exclusion criteria
- willingness to accept group assignment from randomization
- No resistance training and no structured aerobic exercise for > 20 minutes per day, 3+ days per week, for the last 6 months
- conditions that are contraindicated for exercise training
Exclusion Criteria
- Resting blood pressure > 180 mm Hg systolic and/or >100 mm Hg diastolic; individuals on blood pressure medications meeting the blood pressure criteria are eligible
- Diagnosis of type 1 or 2 diabetes, and/or fasting glucose >125 mg/dL
- Medication for the treatment of type 1 or type 2 diabetes
- Bariatric surgery including gastric banding or bypass (potential effects on energy intake)
- Factors that may limit adherence to intervention or affect conduct of the trial
- Unable or unwilling to communicate with staff
- Failure to complete run-in or baseline testing
- Hospitalization for depression or severe mental illness in the last 6 months
- Not physically capable of performing the exercise required of the study protocol
- Consuming more than 14 alcoholic beverages per week
- Plan to be away from the Pitt County area more than 3 weeks in the next 3 months
- Lack support from a primary health care provider or family members
- Significant weight loss in the past year (> 20 pounds) or are currently using weight loss medications.
- Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- Another member of the household who is currently a participant or staff member of this study
- Other temporary intervening event, such as sick spouse, or bereavement
- Other medical, psychiatric, or behavioral limitations that may interfere with study participation or the ability to follow the intervention protocol
- Underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
- Cancer requiring treatment in the past 5 years with anything but excellent prognosis
- Self-reported HIV, tuberculosis, Hepatitis B, or Hepatitis C
- History or evidence of serious arrhythmias, cardiomyopathy, congestive heart failure, aortic aneurism, myocardial infarction or heart transplantation
- Renal disease: urine protein > 100 mg/dl, serum creatinine ≥ 1.5 mg/dl or currently receiving dialysis.
- Auto-immune diseases (such as Lupus, Multiple Sclerosis, Graves' disease, or Rheumatoid arthritis)
- Chronic obstructive lung disease, peripheral vascular disease or angina that limits ability to follow exercise protocol
- History of stroke or transient ischemic attack
- History of vascular aneurysms
- History of bleeding disorders
- Pregnancy or plans to become pregnant
- Dieting or plans to diet, or in a weight loss program
- Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise.
Data sourced from ClinicalTrials.gov (NCT02892331). 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.