PreDiabetesGLYDENCT03154073
Effects of Progressive Intensity Exercise Training on Glycemic Control in Older Adults
A study testing Moderate Intensity Exercise Training (MOD) and Vigorous Intensity Exercise Training (VIG) in people with PreDiabetes and Aging, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Aging
- What is being tested?
- Moderate Intensity Exercise Training (MOD) and Vigorous Intensity Exercise Training (VIG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 13 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- Participating in >30 minutes of aerobic exercise/week during the past 3 months
- Inability to complete exercise test
- Sleep Apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- PreDiabetes, Aging
- Being tested
- Moderate Intensity Exercise Training (MOD), Vigorous Intensity Exercise Training (VIG)
- Keywords
- Exercise, Physical activity, Blood glucose, Sleep
- Medical subject headings
- Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Exercise Training (MOD)Behavioural
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.
Vigorous Intensity Exercise Training (VIG)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Exercise Training | Experimental | Exercise training program that will focus on engaging in ~150 minutes of moderate intensity exercise per week. Exercise will be supervised by trained staff. Receives: Behavioral: Moderate Intensity Exercise Training (MOD) |
| Vigorous Exercise Training | Experimental | Exercise training program that will focus on engaging in ~150 minutes of vigorous intensity exercise per week. Exercise will be supervised by trained staff. Receives: Behavioral: Vigorous Intensity Exercise Training (VIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0 weeks), Post Intervention (12 weeks)
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.
Measured: Baseline (0 weeks), Post Intervention (12 weeks)
Secondary outcomes (6)
Change in Sedentary Time
Measured using a wearable device (min/day)
Measured: Baseline (0 weeks), Post Intervention (12 weeks)
Change in Non-Exercise Physical Activity
Measured using a wearable device (min/day)
Measured: Baseline (0 weeks), Post Intervention (12 weeks)
Change in Total Daily Energy Expenditure
Measured via doubly labeled water (kcals/day)
Measured: Baseline (0 weeks), Post Intervention (12 weeks)
Change in Sleep Duration - 1
Measured using a wearable device
Measured: Baseline (0 weeks), Post Intervention (12 weeks)
Change in Sleep Duration - 2
Measured using a questionnaire
Measured: Baseline (0 weeks), Post Intervention (12 weeks)
Change in 24-hour Glycemic Control (glucose AUC)
Measured using a continuous glucose monitor (glucose AUC)
Measured: Baseline (0 weeks), Post Intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start20 Jul 2017
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth A Creasy, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154073
- Sponsor's protocol ID
- 16-2662
- Other IDs
- F32DK116402
- Acronym
- GLYDE
- Status last verified
- Jul 2021
- First submitted
- 10 May 2017
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Intensity Exercise Training on Glycemic Control in Older Adults Who Are at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT03154073
- Acronym / sponsor ID
- GLYDE / 16-2662
- Conditions
- PreDiabetes, Aging
- Keywords
- Exercise, Physical activity, Blood glucose, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Exercise Training | Experimental | Behavioral: Moderate Intensity Exercise Training (MOD)Exercise training program that will focus on engaging in ~150 minutes of moderate intensity exercise per week. Exercise will be supervised by trained staff. |
| Vigorous Exercise Training | Experimental | Behavioral: Vigorous Intensity Exercise Training (VIG)Exercise training program that will focus on engaging in ~150 minutes of vigorous intensity exercise per week. Exercise will be supervised by trained staff. |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Moderate Exercise Training |
| 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. | Behavioural | Vigorous Exercise Training |
Primary outcome
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.
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.
6 secondary outcomes
Change in Sedentary Time
Time frame: Baseline (0 weeks), Post Intervention (12 weeks)
Change in Non-Exercise Physical Activity
Time frame: Baseline (0 weeks), Post Intervention (12 weeks)
Change in Total Daily Energy Expenditure
Time frame: Baseline (0 weeks), Post Intervention (12 weeks)
Change in Sleep Duration - 1
Time frame: Baseline (0 weeks), Post Intervention (12 weeks)
Change in Sleep Duration - 2
Time frame: Baseline (0 weeks), Post Intervention (12 weeks)
Change in 24-hour Glycemic Control (glucose AUC)
Time frame: Baseline (0 weeks), Post Intervention (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth A Creasy, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Exercise Training (MOD) and Vigorous Intensity Exercise Training (VIG) in people with PreDiabetes and Aging, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glucose Area Under the Curve (AUC) (time frame: Baseline (0 weeks), Post Intervention (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.