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Effects of Exercise Training Intensity on Fitness and Insulin Sensitivity in African Americans (HI-PACE)

Primary Purpose

Obesity, Insulin Resistance, Sedentary Lifestyle

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Moderate intensity exercise training (MOD-INT)

High Intensity exercise training (HI-INT)

About this trial

This is an interventional prevention trial for Obesity focused on measuring exercise, insulin resistance, mitochondrial function, arterial stiffness, exercise intensity, fitness

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

East Carolina UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Control

MOD-INT

HIGH-INT

Arm Description

This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete

The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks

High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks

Outcomes

Primary Outcome Measures

Change in cardiorespiratory fitness

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. Respiratory gases (VO2, CO2) and ventilation will be measured continuously using a True Max 2400 Metabolic Measurement Cart (Parvomedics, Salt Lake City Utah).

Secondary Outcome Measures

Change in body composition

Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass.

Change in body weight

Weight will be measured using a calibrated scale

Change in waist circumference

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.

Changes in physical activity levels

Participants will wear an ActivPal accelerometer for seven consecutive days, 24-hrs/day. The amount of time spent sitting and standing and steps will be calculated

Change in dietary composition

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.

Changes in blood lipids concentrations

Low density lipoproteins, high density lipoproteins, total cholesterol, and triglycerides will be measured from baseline and 24 weeks from blood samples by Labcorp Inc.

Change in systemic inflammation

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

Change in insulin sensitivity

Insulin sensitivity will be measured using an intravenous glucose tolerance test

Change in arterial stiffness

Arterial stiffness will be measured using pulse wave velocity.

Change in quality of life

Quality of life (QOL) will be measured by the short form health survey (SF-36)

Change in mitochondrial enzymes and protein content

Mitochondrial enzymes (citrate synthase, COX IV, GLUT-4, CPT-1) protein content (COX IV, GLUT-4 CPT-1 and PGC-1 alpha)

Full Information

NCT ID

NCT02892331

First Posted

August 30, 2016

Last Updated

February 5, 2018

Sponsor

East Carolina University

1. Study Identification

Unique Protocol Identification Number

NCT02892331

Brief Title

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

Acronym

HI-PACE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

East Carolina University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Insulin Resistance, Sedentary Lifestyle

Keywords

exercise, insulin resistance, mitochondrial function, arterial stiffness, exercise intensity, fitness

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

This group does not change physical activity during the intervention period, but will receive exercise training after the study is complete

Arm Title

MOD-INT

Arm Type

Experimental

Arm Description

The Moderate intensity exercise training (MOD-INT) group will exercise at a moderate aerobic exercise intensity for 24 weeks

Arm Title

HIGH-INT

Arm Type

Experimental

Arm Description

High Intensity exercise training (HI-INT) group will exercise at a high aerobic intensity for 24 weeks

Intervention Type

Behavioral

Intervention Name(s)

Moderate intensity exercise training (MOD-INT)

Intervention Description

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)

Intervention Type

Behavioral

Intervention Name(s)

High Intensity exercise training (HI-INT)

Intervention Description

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 Outcome Measure Information:

Title

Change in cardiorespiratory fitness

Description

Time Frame

Baseline and 24 weeks

Secondary Outcome Measure Information:

Title

Change in body composition

Description

Dual-energy X-ray absorptiometry will be used to measure changes in fat and lean mass.

Time Frame

Baseline and 24 weeks

Title

Change in body weight

Description

Weight will be measured using a calibrated scale

Time Frame

Baseline and 24 weeks

Title

Change in waist circumference

Description

Time Frame

Baseline and 24 weeks

Title

Changes in physical activity levels

Description

Participants will wear an ActivPal accelerometer for seven consecutive days, 24-hrs/day. The amount of time spent sitting and standing and steps will be calculated

Time Frame

Baseline and 24 Weeks

Title

Change in dietary composition

Description

Time Frame

Baseline and 24 weeks

Title

Changes in blood lipids concentrations

Description

Low density lipoproteins, high density lipoproteins, total cholesterol, and triglycerides will be measured from baseline and 24 weeks from blood samples by Labcorp Inc.

Time Frame

Baseline and 24 weeks

Title

Change in systemic inflammation

Description

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

Time Frame

Baseline and 24 weeks

Title

Change in insulin sensitivity

Description

Insulin sensitivity will be measured using an intravenous glucose tolerance test

Time Frame

Baseline and 24 weeks

Title

Change in arterial stiffness

Description

Arterial stiffness will be measured using pulse wave velocity.

Time Frame

Baseline and 24 weeks

Title

Change in quality of life

Description

Quality of life (QOL) will be measured by the short form health survey (SF-36)

Time Frame

Baseline and 24 weeks

Title

Change in mitochondrial enzymes and protein content

Description

Mitochondrial enzymes (citrate synthase, COX IV, GLUT-4, CPT-1) protein content (COX IV, GLUT-4 CPT-1 and PGC-1 alpha)

Time Frame

Baseline and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Damon L Swift, Ph.D.

Phone

252-737-1338

swiftd@ecu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Patricia Brophy, M.A.

Phone

252-737-1600

brophyp@ecu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Damon L Swift, Ph.D.

Organizational Affiliation

East Carolina University

Official's Role

Principal Investigator

Facility Information:

Facility Name

East Carolina University

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27858

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Damon L Swift, Ph.D.

Phone

252-737-1338

swiftd@ecu.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31395096

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.

Results Reference

derived

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

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