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CompletedNCT00701051Updated Apr 6, 2015Results posted

Exercise Training and Glucose Metabolism in Aging

An interventional study of Aerobic exercise training and Detraining (cessation of exercise) in Type 2 Diabetes Mellitus and Impaired Glucose Tolerance (Prediabetes), sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-06.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
50 Years to 75 Years
Sex
All
01

Study summary

Diabetes and its associated complications affect more than 20 million Americans, and the prevalence of type 2 diabetes and impaired glucose tolerance rises dramatically with age such that 40% of Americans over age 60 are affected. In older adults, glucose metabolism may be affected by reduced skeletal muscle capillary supply, which limits insulin, glucose, and oxygen delivery to skeletal muscle. Reduced capillary supply to skeletal muscle is found in older individuals with impaired glucose tolerance and we hypothesize that this is due to reduced vascular growth factor expression, and chronic inflammation. Further, we hypothesize that reversal of a sedentary lifestyle through aerobic exercise training will increase insulin signaling and vascular growth factor expression, as well as decrease inflammation, to increase capillary supply to skeletal muscle, which contributes to improved glucose metabolism in older adults. This study will: 1) Determine the mechanisms underlying reduced skeletal muscle capillarization in older adults with impaired glucose tolerance; and 2) Determine the effect of aerobic exercise training-induced increases in skeletal muscle capillarization on glucose metabolism in older adults.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Impaired Glucose Tolerance (Prediabetes)
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 90 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 675 studies on the registry; none are open to participants now.

Browse US Department of Veterans Affairs studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 50-75 years
  • Non-smoker >2 years
  • Body mass index = 18-35 kg/m2

Exclusion criteria

Exclusion Criteria:

  • History of CAD or cerebrovascular disease that would preclude exercise
  • Implantable defibrillator
  • Active cancer
  • Chronic pulmonary, thyroid, renal, liver, or hematological disease
  • HIV positive or prone to malnutrition
  • Sickle cell anemia
  • Type 1 diabetes, or currently on medication to treat type 2 diabetes
  • Poorly-controlled type 2 diabetes
  • Poorly-controlled hypertension
  • Taking medications including: beta-blockers, oral steroids, warfarin, certain statins, hormone replacement therapy (HRT), oral contraceptives (OCP), thiazolidinediones (TZD), or chronic steroids or nonsteroidal analgesics (NSAIDS) that may not be safely discontinued temporarily for specific procedures (i.e. for 72 hours prior)
  • Allergic to lidocaine or heparin
  • Recent weight change (>5kg in 3 months)
  • Currently pregnant or nursing
  • Physical impairment limiting exercise
  • Dementia or unstable clinical depression
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Arm 1

    Older adults, normal glucose tolerance

    Behavioral: Aerobic exercise training · Behavioral: Detraining (cessation of exercise)

  • Experimental
    Arm 2

    Older adults, impaired glucose tolerance

    Behavioral: Aerobic exercise training · Behavioral: Detraining (cessation of exercise)

Interventions

  • BehavioralAerobic exercise training

    24 weeks of aerobic exercise training: 3 times per week, 60 minutes per session, at 70% of maximal aerobic capacity

  • BehavioralDetraining (cessation of exercise)

    Cessation of exercise for 2 weeks

06

What researchers measure

Primary outcomes

  1. Baseline Glucose Utilization

    Insulin-stimulated glucose uptake

    Time frame: baseline

  2. Glucose Utilization (Pre/Post Intervention)

    Insulin-stimulated glucose uptake

    Time frame: baseline, 24 weeks, 26 weeks

  3. Baseline Skeletal Muscle Capillarization

    Time frame: baseline

  4. Skeletal Muscle Capillarization (Pre/Post Intervention)

    Time frame: baseline, 24 weeks, 26 weeks

Secondary outcomes

  1. Baseline 2-hour Postprandial Glucose

    Time frame: baseline

  2. 2-hr Post-prandial Plasma Glucose Level

    Time frame: baseline, 24 weeks, 26 weeks

  3. Baseline Cardiorespiratory Fitness

    maximal oxygen consumption

    Time frame: baseline

  4. Cardiorespiratory Fitness

    Maximal oxygen consumption

    Time frame: baseline, 24 weeks, 26 weeks

  5. Body Composition (%Fat)

    Time frame: baseline, 24 weeks

07

Results

Posted Apr 6, 2015

Participant flow

Screening
Participant flow — Screening
MilestoneOlder AdultsOlder Adults - Normal Glucose ToleranceOlder Adults - Impaired Glucose Tolerance
Started9000
Completed3100
Not completed5900
Withdrew: Failed screening4000
Withdrew: Time conflicts1900
Exercise Intervention
Participant flow — Exercise Intervention
MilestoneOlder AdultsOlder Adults - Normal Glucose ToleranceOlder Adults - Impaired Glucose Tolerance
Started01912
Completed0149
Not completed053
Withdrew: Time conflict; non-study related illness053
Detraining Intervention (Optional)
Participant flow — Detraining Intervention (Optional)
MilestoneOlder AdultsOlder Adults - Normal Glucose ToleranceOlder Adults - Impaired Glucose Tolerance
Started066
Completed066
Not completed000

Outcome measures

PrimaryBaseline Glucose Utilization

Insulin-stimulated glucose uptake

Time frame:
baseline
Reported as:
Mean · µmol/kgFFM/pmol insulin/min
Baseline Glucose Utilization
µmol/kgFFM/pmol insulin/minOlder Adults - Normal Glucose ToleranceOlder Adults - Impaired Glucose Tolerance
Baseline Glucose Utilization0.0062 ± .000080.0035 ± 0.0004
SecondaryBaseline 2-hour Postprandial Glucose
Time frame:
baseline
Reported as:
Mean · mg/dl
Baseline 2-hour Postprandial Glucose
mg/dlOlder Adults - Normal Glucose ToleranceOlder Adults - Impaired Glucose Tolerance
Baseline 2-hour Postprandial Glucose107 ± 2160 ± 10
PrimaryGlucose Utilization (Pre/Post Intervention)

Insulin-stimulated glucose uptake

Time frame:
baseline, 24 weeks, 26 weeks
Reported as:
Mean · µmol/kgFFM/pmol insulin/min
Glucose Utilization (Pre/Post Intervention)
µmol/kgFFM/pmol insulin/minOlder Adults
Baseline0.041 ± 0.005
24-week0.052 ± 0.006
26-week0.048 ± 0.005
Secondary2-hr Post-prandial Plasma Glucose Level
Time frame:
baseline, 24 weeks, 26 weeks
Reported as:
Mean · mg/dL
2-hr Post-prandial Plasma Glucose Level
mg/dLOlder Adults
Baseline173 ± 8
24-week153 ± 16
26-week142 ± 19
SecondaryBaseline Cardiorespiratory Fitness

maximal oxygen consumption

Time frame:
baseline
Reported as:
Mean · L/min
Baseline Cardiorespiratory Fitness
L/minOlder Adults - Normal Glucose ToleranceOlder Adults - Impaired Glucose Tolerance
Baseline Cardiorespiratory Fitness2.2 ± 0.31.7 ± 0.2
PrimaryBaseline Skeletal Muscle Capillarization
Time frame:
baseline
Reported as:
Mean · capillaries/mm2
Baseline Skeletal Muscle Capillarization
capillaries/mm2Older Adults - Normal Glucose ToleranceOlder Adults - Impaired Glucose Tolerance
Baseline Skeletal Muscle Capillarization313 ± 13246 ± 8
PrimarySkeletal Muscle Capillarization (Pre/Post Intervention)
Time frame:
baseline, 24 weeks, 26 weeks
Reported as:
Mean · capillaries/mm2
Skeletal Muscle Capillarization (Pre/Post Intervention)
capillaries/mm2Older Adults
Baseline289 ± 12
24-week341 ± 21
26-week361 ± 10
SecondaryCardiorespiratory Fitness

Maximal oxygen consumption

Time frame:
baseline, 24 weeks, 26 weeks
Reported as:
Mean · L/Min
Cardiorespiratory Fitness
L/MinOlder Adults
Baseline1.8 ± 0.1
24-week2.3 ± 0.5
26-week2.2 ± 0.5
SecondaryBody Composition (%Fat)
Time frame:
baseline, 24 weeks
Reported as:
Mean · percentage of fat
Body Composition (%Fat)
percentage of fatOlder Adults
Baseline35 ± 3
24-week33 ± 3

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Older Adults—0/90 (0%)1/90 (1.1%)
Most frequent other events
Most frequent other events
EventOlder Adults
FallMusculoskeletal and connective tissue disorders1/90

Baseline characteristics

Age, Continuous
Age, Continuous(years)Older Adults - Normal Glucose ToleranceOlder Adults - Impaired Glucose ToleranceTotal
Mean60 ± 760 ± 860 ± 7
Sex: Female, Male
Sex: Female, Male(Participants)Older Adults - Normal Glucose ToleranceOlder Adults - Impaired Glucose ToleranceTotal
Female9615
Male10616
08

Study locations

1 site
  • VA Maryland Health Care System, Baltimore
    Baltimore, Maryland 21201, United States
09

References and documents

Publications

  • Prior SJ, Goldberg AP, Ortmeyer HK, Chin ER, Chen D, Blumenthal JB, Ryan AS. Increased Skeletal Muscle Capillarization Independently Enhances Insulin Sensitivity in Older Adults After Exercise Training and Detraining. Diabetes. 2015 Oct;64(10):3386-95. doi: 10.2337/db14-1771. Epub 2015 Jun 11. PubMed 26068543 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2006, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2015, 2 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2008
First posted
Jun 19, 2008
Start
Oct 2006
Primary completionActual
Jun 2012
CompletionActual
Jun 2012
Results first posted
Apr 6, 2015
Last update
Apr 6, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00701051
Lead sponsor
US Department of Veterans Affairs
Collaborators
University of Maryland, National Institutes of Health (NIH), National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Jun 19, 2008
Start date
Oct 2006
Primary completion
Jun 2012
Completion
Jun 2012
Results posted
Apr 6, 2015
Last update
Apr 6, 2015

Study contacts

Steven J. Prior, PhD
principal investigator · VA Maryland Health Care System, Baltimore

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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