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Effects of Progressive Intensity Exercise Training on Glycemic Control in Older Adults (GLYDE)

Primary Purpose

PreDiabetes, Aging

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Moderate Intensity Exercise Training (MOD)

Vigorous Intensity Exercise Training (VIG)

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Exercise, Physical activity, Blood glucose, Sleep

Eligibility Criteria

60 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age ≥60 to <80 years upon study entry
Body mass index ≥25.0 to <35.0 kg/m2 as measured at the baseline screening visit
HBA1c ≥ 5.7% to <6.5% OR Fasting Glucose ≥ 100 to <126 mg/dl as measured at the baseline screening visit.

Exclusion Criteria:

History of metabolic, cardiac, or pulmonary disease that classifies the individual as high risk by the American College of Sports Medicine
Participants with un-controlled hypertension and un-controlled thyroid disorders and are on medication for <3 months.
Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg will be exclusionary. At the baseline screening visit, an initial resting blood pressure measurement will be attained after the participant is seated at rest for 5 minutes. Subsequent resting blood pressure measurements can be taken at the baseline screening visit up to 3 times to determine eligibility. Subsequent measurements will be taken under the same conditions as the initial measurement with a minimum of 5 minutes between readings. If more than one reading is needed to determine eligibility, the average of all readings taken will be used.
Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement.
Self-reported chronic Inflammatory Disease (e.g., rheumatoid arthritis, lupus)
Currently taking statins, hormone replacement therapy, prescribed sleep medications, or medications that may affect heart rate response to exercise (e.g., beta blockers)
Participating in >30 minutes of aerobic exercise/week during the past 3 months
Inability to complete exercise test
Sleep Apnea

Sites / Locations

University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Moderate Exercise Training

Vigorous Exercise Training

Arm Description

Exercise training program that will focus on engaging in ~150 minutes of moderate intensity exercise per week. Exercise will be supervised by trained staff.

Exercise training program that will focus on engaging in ~150 minutes of vigorous intensity exercise per week. Exercise will be supervised by trained staff.

Outcomes

Primary Outcome Measures

Change in Glucose Area Under the Curve (AUC)

Glucose will be assessed at 0, 10, 20, 30, 60, 90, 120, 180 minutes. These measurements will be used to calculate glucose AUC.

Insulin Sensitivity Index (μmol·kg^-1·min^-1·pM^-1)

Glucose, insulin, and c-peptide will be assessed at 0, 10, 20, 30, 60, 90, 120, 180 minutes . Height will be measured using a wall mounted stadiometer (cm). Weight will be assessed using a digital scale (kg). Collectively these measurements will be used to calculate BMI (kg/m^2). All of these measurement will be used to assess Insulin sensitivity index as determined by the regression model validated by Stumvoll.

Secondary Outcome Measures

Change in Sedentary Time

Measured using a wearable device (min/day)

Change in Non-Exercise Physical Activity

Measured using a wearable device (min/day)

Change in Total Daily Energy Expenditure

Measured via doubly labeled water (kcals/day)

Change in Sleep Duration - 1

Measured using a wearable device

Change in Sleep Duration - 2

Measured using a questionnaire

Change in 24-hour Glycemic Control (glucose AUC)

Measured using a continuous glucose monitor (glucose AUC)

Full Information

NCT ID

NCT03154073

First Posted

May 10, 2017

Last Updated

July 2, 2021

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT03154073

Brief Title

Effects of Progressive Intensity Exercise Training on Glycemic Control in Older Adults

Acronym

GLYDE

Official Title

Effects of Progressive Intensity Exercise Training on Glycemic Control in Older Adults Who Are at Risk for Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

July 20, 2017 (Actual)

Primary Completion Date

December 13, 2019 (Actual)

Study Completion Date

December 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the effects of moderate versus vigorous intensity exercise training on glycemic control in older adults. Glycemic control will be assessed using an oral glucose tolerance test and continuous glucose monitors. In addition, the investigaotrs will investigate whether engaging in an exercise training program elicits changes in sedentary behavior, non-exercise physical activity, sleep, and total daily energy expenditure.

Detailed Description

Approximately 25% of older adults have type 2 diabetes mellitus, and almost 50% of older adults have prediabetes. Identifying strategies to prevent the progression of diabetes in this older adult population is imperative. One strategy that has shown promise is lifestyle modification. As adults age they also increase sedentary behavior, decrease physical activity, and have increased occurrence of sleep problems. The combination of these lifestyle factors are likely responsible for the decreases in glycemic control with aging. The American Diabetes Association recommends that prediabetic adults, including older adults, increase structured aerobic exercise and incidental (non-exercise) physical activity while decreasing sedentary behavior. It is emphasized that structured exercise is the most important of these recommendations. However, initiating an exercise routine, may unintentionally affect time spent sitting, non-exercise physical activity, and other lifestyle behaviors like sleep. These changes may attenuate or enhance the effects of exercise on glycemic control. This study will compare the effects of moderate and high intensity exercise on glycemic control, and determine whether changes in non-exercise physical activity, sitting time, and sleep are associated with the observed changes. Because of the increasing prevalence of diabetes with age, identifying the optimal exercise prescription to preserve glycemic control in older adults has important clinical implications.

6. Conditions and Keywords

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

PreDiabetes, Aging

Keywords

Exercise, Physical activity, Blood glucose, Sleep

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moderate Exercise Training

Arm Type

Experimental

Arm Description

Exercise training program that will focus on engaging in ~150 minutes of moderate intensity exercise per week. Exercise will be supervised by trained staff.

Arm Title

Vigorous Exercise Training

Arm Type

Experimental

Arm Description

Exercise training program that will focus on engaging in ~150 minutes of vigorous intensity exercise per week. Exercise will be supervised by trained staff.

Intervention Type

Behavioral

Intervention Name(s)

Moderate Intensity Exercise Training (MOD)

Intervention Description

For the first 4 weeks, participant will be asked to complete 3 days of exercise/week at 50-65% heart rate maximum. Sessions will last between 30-40 minutes excluding the warm-up and cool down (5-10 minutes). After 4 weeks, the MOD group will be expected to match the exercise prescription. The exercise prescription for the MOD group for weeks 5-12 will be 4 days/week, 45 min/session completed at 60-65% heart rate maximum.

Intervention Type

Behavioral

Intervention Name(s)

Vigorous Intensity Exercise Training (VIG)

Intervention Description

The exercise lead in period will be the same as the moderate intensity exercise training program. After 6 weeks, the VIG group will be expected to match the exercise prescription. The exercise prescription for the VIG for weeks 7-12 will be 4 days/week, 45 min/session completed at 80-85% heart rate maximum.

Primary Outcome Measure Information:

Title

Change in Glucose Area Under the Curve (AUC)

Description

Glucose will be assessed at 0, 10, 20, 30, 60, 90, 120, 180 minutes. These measurements will be used to calculate glucose AUC.

Time Frame

Baseline (0 weeks), Post Intervention (12 weeks)

Title

Insulin Sensitivity Index (μmol·kg^-1·min^-1·pM^-1)

Description

Time Frame

Baseline (0 weeks), Post Intervention (12 weeks)

Secondary Outcome Measure Information:

Title

Change in Sedentary Time

Description

Measured using a wearable device (min/day)

Time Frame

Baseline (0 weeks), Post Intervention (12 weeks)

Title

Change in Non-Exercise Physical Activity

Description

Measured using a wearable device (min/day)

Time Frame

Baseline (0 weeks), Post Intervention (12 weeks)

Title

Change in Total Daily Energy Expenditure

Description

Measured via doubly labeled water (kcals/day)

Time Frame

Baseline (0 weeks), Post Intervention (12 weeks)

Title

Change in Sleep Duration - 1

Description

Measured using a wearable device

Time Frame

Baseline (0 weeks), Post Intervention (12 weeks)

Title

Change in Sleep Duration - 2

Description

Measured using a questionnaire

Time Frame

Baseline (0 weeks), Post Intervention (12 weeks)

Title

Change in 24-hour Glycemic Control (glucose AUC)

Description

Measured using a continuous glucose monitor (glucose AUC)

Time Frame

Baseline (0 weeks), Post Intervention (12 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥60 to <80 years upon study entry Body mass index ≥25.0 to <35.0 kg/m2 as measured at the baseline screening visit HBA1c ≥ 5.7% to <6.5% OR Fasting Glucose ≥ 100 to <126 mg/dl as measured at the baseline screening visit. Exclusion Criteria: History of metabolic, cardiac, or pulmonary disease that classifies the individual as high risk by the American College of Sports Medicine Participants with un-controlled hypertension and un-controlled thyroid disorders and are on medication for <3 months. Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg will be exclusionary. At the baseline screening visit, an initial resting blood pressure measurement will be attained after the participant is seated at rest for 5 minutes. Subsequent resting blood pressure measurements can be taken at the baseline screening visit up to 3 times to determine eligibility. Subsequent measurements will be taken under the same conditions as the initial measurement with a minimum of 5 minutes between readings. If more than one reading is needed to determine eligibility, the average of all readings taken will be used. Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement. Self-reported chronic Inflammatory Disease (e.g., rheumatoid arthritis, lupus) Currently taking statins, hormone replacement therapy, prescribed sleep medications, or medications that may affect heart rate response to exercise (e.g., beta blockers) Participating in >30 minutes of aerobic exercise/week during the past 3 months Inability to complete exercise test Sleep Apnea

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seth A Creasy, PhD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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