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

July 2, 2021 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Moderate Exercise Training
Exercise training program that will focus on engaging in ~150 minutes of moderate intensity exercise per week. Exercise will be supervised by trained staff.
Behavioral: Moderate Intensity Exercise Training (MOD)
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.
Experimental: Vigorous Exercise Training
Exercise training program that will focus on engaging in ~150 minutes of vigorous intensity exercise per week. Exercise will be supervised by trained staff.
Behavioral: Vigorous Intensity Exercise Training (VIG)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Glucose Area Under the Curve (AUC)
Time Frame: Baseline (0 weeks), Post Intervention (12 weeks)
Glucose will be assessed at 0, 10, 20, 30, 60, 90, 120, 180 minutes. These measurements will be used to calculate glucose AUC.
Baseline (0 weeks), Post Intervention (12 weeks)
Insulin Sensitivity Index (μmol·kg^-1·min^-1·pM^-1)
Time Frame: Baseline (0 weeks), Post Intervention (12 weeks)
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.
Baseline (0 weeks), Post Intervention (12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Sedentary Time
Time Frame: Baseline (0 weeks), Post Intervention (12 weeks)
Measured using a wearable device (min/day)
Baseline (0 weeks), Post Intervention (12 weeks)
Change in Non-Exercise Physical Activity
Time Frame: Baseline (0 weeks), Post Intervention (12 weeks)
Measured using a wearable device (min/day)
Baseline (0 weeks), Post Intervention (12 weeks)
Change in Total Daily Energy Expenditure
Time Frame: Baseline (0 weeks), Post Intervention (12 weeks)
Measured via doubly labeled water (kcals/day)
Baseline (0 weeks), Post Intervention (12 weeks)
Change in Sleep Duration - 1
Time Frame: Baseline (0 weeks), Post Intervention (12 weeks)
Measured using a wearable device
Baseline (0 weeks), Post Intervention (12 weeks)
Change in Sleep Duration - 2
Time Frame: Baseline (0 weeks), Post Intervention (12 weeks)
Measured using a questionnaire
Baseline (0 weeks), Post Intervention (12 weeks)
Change in 24-hour Glycemic Control (glucose AUC)
Time Frame: Baseline (0 weeks), Post Intervention (12 weeks)
Measured using a continuous glucose monitor (glucose AUC)
Baseline (0 weeks), Post Intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-2662
  • F32DK116402 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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