Clinical trial NCT02892331: Effects of Exercise Training Intensity on Fitness and Insulin Sensitivity in African Americans
Official title: The High Intensity Exercise to Promote Accelerated Improvements in CardiorEspiratory Fitness (HI-PACE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Sedentary Lifestyle
Keywords: exercise
insulin resistance
mitochondrial function
arterial stiffness
exercise intensity
fitness
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 52
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: African Americans have a much greater risk of type 2 diabetes compared to Caucasians in the United States. Similarly, recent evidence has emerged that fitness level, a major risk factor for type 2 diabetes also tends to be lower in African Americans. Many scientific studies have shown that exercise training has a beneficial impact on fitness levels and a variety of other type 2 diabetes risk factors such as the reduction of glucose/insulin levels, and body fat Importantly, studies performed in mostly Caucasian populations suggest that exercise training at a vigorous intensity may promote greater improvements in type 2 diabetes risk factors compared to moderate intensity exercise, which may suggest that it has greater promise in reducing type 2 diabetes risk. However, few exercise training studies compare the health benefits of different exercise training programs (such as exercise intensity) in African Americans, which is clinically important due to their greater type 2 diabetes risk, and that fact that they are less likely to meet public health recommendations for physical activity compared to their Caucasian counterparts.

The High Intensity exercise to Promote Accelerated improvements in CardiorEspiratory fitness (HI-PACE) study will evaluate the effect of exercise intensity on cardiorespiratory fitness (CRF) and insulin sensitivity in obese (BMI: 30-45) African Americans (40-65 yrs.) with at least 1 additional T2D risk factor. Participants (n=60) will be recruited in collaboration with the ECU Center for Health Disparities, and subsequently randomized to moderate intensity (MOD-INT, n=20) or high intensity (HIGH-INT, n=20) aerobic exercise training, or to a control group (CON, n=20) for 24 weeks. Supervised exercise training will be performed at a heart rate associated with \~50% and \~75% of VO2 max in the MOD-INT and the HIGH-INT groups, respectively at the same exercise volume of 600 MET-minutes per week (consistent with public health recommendations). The primary outcome is the change in CRF, which will be assessed at baseline, mid-intervention, and follow-up. Insulin sensitivity will be measured via an intravenous glucose tolerance test at baseline and follow-up. Other secondary measures include mitochondrial oxidative capacity using infrared and measurements on muscle biopsies (PGC-1α and other indices of mitochondrial content), the expression of a protein involved with insulin action (GLUT-4 expression) in skeletal muscle as well as systemic inflammation, adiposity, quality of life and exercise enjoyment measures.

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.

Primary outcomes:
measure: Change in Cardiorespiratory Fitness
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change in Body Fat Percentage
timeFrame: Baseline and 24 weeks
measure: Change in Body Weight
timeFrame: Baseline and 24 weeks
measure: Change in Waist Circumference
timeFrame: Baseline and 24 weeks
measure: Change in Low Density Lipoprotein
timeFrame: Baseline and 24 Weeks
measure: Change in High Density Lipoprotein
timeFrame: Baseline and 24 Weeks
measure: Changes in Total Cholesterol
timeFrame: Baseline and 24 weeks
measure: Change in Triglycerides
timeFrame: Baseline and 24 Weeks
measure: Change in Systemic Inflammation
timeFrame: Baseline and 24 weeks
measure: Change in Fasting Glucose
timeFrame: Baseline and 24 Weeks
measure: Change in Insulin
timeFrame: Baseline and 24 Weeks
measure: Change in Insulin Sensitivity
timeFrame: Baseline and 24 weeks
measure: Change in Arterial Stiffness
timeFrame: Baseline and 24 weeks
measure: Change in Mitochondrial Enzymes
timeFrame: Baseline and 24 weeks
measure: Change in Quality of Life
timeFrame: Baseline and 24 weeks
measure: Change in Quality of Life (Mental Health and Physical Health Summary Scores)
timeFrame: Baseline to 24 Weeks
measure: Changes in Physical Activity Levels
timeFrame: Baseline and 24 Weeks
measure: Change in Dietary Composition
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Damon L Swift, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGee JE, Barefoot SG, Gniewek NR, Brophy PM, Clark A, Dubis GS, Ryan TE, Houmard JA, Vos P, Raedeke TD, Swift DL. High-intensity exercise to promote accelerated improvements in cardiorespiratory fitness (HI-PACE): study protocol for a randomized controlled trial. Trials. 2019 Aug 8;20(1):484. doi: 10.1186/s13063-019-3611-1.