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Completed

NCT Number: NCT02892331

Effects of Exercise Training Intensity on Fitness and Insulin Sensitivity in African Americans

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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University

Greenville, North Carolina, 27858, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moderate intensity exercise training (MOD-INT)

Behavioral

Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)

High Intensity exercise training (HI-INT)

Behavioral

Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3

Primary outcomes

  1. Change in Cardiorespiratory Fitness

    Time frame: Baseline and 24 weeks

    Fitness will be measured using a modified Balke protocol on a treadmill. Participants will walk at an initial speed of 2.0 mph with 0% grade for the first 3 minutes after which the treadmill speed will increase to 3.0 mph for the next 3 minutes. The treadmill grade will be increased by 2.5% every 3 minutes until volitional exhaustion. Maximal oxygen consumption (Liters of O2 per minute) will be measured using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah).

Secondary outcomes

  1. Change in Body Fat Percentage

    Time frame: Baseline and 24 weeks

    Dual-energy X-ray absorptiometry will be used to measure changes in body fat percentage

  2. Change in Body Weight

    Time frame: Baseline and 24 weeks

    Weight will be measured using a calibrated scale. Weight will be measured in kg

  3. Change in Waist Circumference

    Time frame: Baseline and 24 weeks

    Waist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a Gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes.

  4. Change in Low Density Lipoprotein

    Time frame: Baseline and 24 Weeks

    Low density lipoprotein will be measured from a fasting blood sample

  5. Change in High Density Lipoprotein

    Time frame: Baseline and 24 Weeks

    High density lipoprotein will be measured from a fasted blood sample

  6. Changes in Total Cholesterol

    Time frame: Baseline and 24 weeks

    Total Cholesterol will be measured in a fasting blood sample

  7. Change in Triglycerides

    Time frame: Baseline and 24 Weeks

    Triglyceride levels will be measured from a fasting blood sample

  8. Change in Systemic Inflammation

    Time frame: Baseline and 24 weeks

    High sensitivity c-reactive protein will be measured at baseline and follow-up

  9. Change in Fasting Glucose

    Time frame: Baseline and 24 Weeks

    Fasting glucose will be measured from a fasting blood sample

  10. Change in Insulin

    Time frame: Baseline and 24 Weeks

    Fasting insulin value will be measured from a blood sample

  11. Change in Insulin Sensitivity

    Time frame: Baseline and 24 weeks

    Insulin sensitivity will be measured using an intravenous glucose tolerance test

  12. Change in Arterial Stiffness

    Time frame: Baseline and 24 weeks

    Arterial stiffness will be measured using pulse wave velocity.

  13. Change in Mitochondrial Enzymes

    Time frame: Baseline and 24 weeks

    Mitochondrial enzymes (citrate synthase, pgc1aplha and complex1-5)

  14. Change in Quality of Life

    Time frame: Baseline and 24 weeks

    Quality of life (QOL) will be measured by the short form health survey (SF-36). SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status).

  15. Change in Quality of Life (Mental Health and Physical Health Summary Scores)

    Time frame: Baseline to 24 Weeks

    The SF-36 also produces a measure of overall physical health (physical component score [PCS]) and overall mental health (mental component score [MCS]). Scoring of these items are standardized using means and standard deviations from the general US population. Aggregate PCS and MCS scores are standardized using a linear T-Score transformation to have a mean of 50 and a standard deviation of 10. A higher score indicates better quality of life and a lower score indicates worsened quality of life.

  16. Changes in Physical Activity Levels

    Time frame: Baseline and 24 Weeks

    Participants will wear an ActivPal accelerometer for seven consecutive days, 24-hrs/day. The change in steps will be be evaluated from baseline to 24 weeks

  17. Change in Dietary Composition

    Time frame: Baseline and 24 weeks

    Food Frequency Questionnaire (FFQ) contains approximately 105 items grouped by categories and is completed for both frequency of consumption as well as portion size selections by the individual. The questionnaire, upon completion, provides estimated daily intake values for selected nutrients (kilocalories, macronutrients, and micronutrients) and provides information on food group servings.

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Official study title

The High Intensity Exercise to Promote Accelerated Improvements in CardiorEspiratory Fitness (HI-PACE) Study

Acronym: HI-PACE

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 8, 2016
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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