Exercise Training and Glucose Metabolism in Aging
Primary Purpose
Type 2 Diabetes Mellitus, Impaired Glucose Tolerance (Prediabetes)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise training
Detraining (cessation of exercise)
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Age 50-75 years
- Non-smoker >2 years
- Body mass index = 18-35 kg/m2
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
Sites / Locations
- VA Maryland Health Care System, Baltimore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Older adults, normal glucose tolerance
Older adults, impaired glucose tolerance
Outcomes
Primary Outcome Measures
Baseline Glucose Utilization
Insulin-stimulated glucose uptake
Glucose Utilization (Pre/Post Intervention)
Insulin-stimulated glucose uptake
Baseline Skeletal Muscle Capillarization
Skeletal Muscle Capillarization (Pre/Post Intervention)
Secondary Outcome Measures
Baseline 2-hour Postprandial Glucose
2-hr Post-prandial Plasma Glucose Level
Baseline Cardiorespiratory Fitness
maximal oxygen consumption
Cardiorespiratory Fitness
Maximal oxygen consumption
Body Composition (%Fat)
Full Information
NCT ID
NCT00701051
First Posted
June 18, 2008
Last Updated
March 23, 2015
Sponsor
US Department of Veterans Affairs
Collaborators
University of Maryland, National Institutes of Health (NIH), National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00701051
Brief Title
Exercise Training and Glucose Metabolism in Aging
Official Title
Aging, Angiogenesis and Metabolic Responses to Aerobic Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
University of Maryland, National Institutes of Health (NIH), National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Impaired Glucose Tolerance (Prediabetes)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Older adults, normal glucose tolerance
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Older adults, impaired glucose tolerance
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise training
Intervention Description
24 weeks of aerobic exercise training: 3 times per week, 60 minutes per session, at 70% of maximal aerobic capacity
Intervention Type
Behavioral
Intervention Name(s)
Detraining (cessation of exercise)
Intervention Description
Cessation of exercise for 2 weeks
Primary Outcome Measure Information:
Title
Baseline Glucose Utilization
Description
Insulin-stimulated glucose uptake
Time Frame
baseline
Title
Glucose Utilization (Pre/Post Intervention)
Description
Insulin-stimulated glucose uptake
Time Frame
baseline, 24 weeks, 26 weeks
Title
Baseline Skeletal Muscle Capillarization
Time Frame
baseline
Title
Skeletal Muscle Capillarization (Pre/Post Intervention)
Time Frame
baseline, 24 weeks, 26 weeks
Secondary Outcome Measure Information:
Title
Baseline 2-hour Postprandial Glucose
Time Frame
baseline
Title
2-hr Post-prandial Plasma Glucose Level
Time Frame
baseline, 24 weeks, 26 weeks
Title
Baseline Cardiorespiratory Fitness
Description
maximal oxygen consumption
Time Frame
baseline
Title
Cardiorespiratory Fitness
Description
Maximal oxygen consumption
Time Frame
baseline, 24 weeks, 26 weeks
Title
Body Composition (%Fat)
Time Frame
baseline, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 50-75 years
Non-smoker >2 years
Body mass index = 18-35 kg/m2
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J. Prior, PhD
Organizational Affiliation
VA Maryland Health Care System, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Maryland Health Care System, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26068543
Citation
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.
Results Reference
derived
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Exercise Training and Glucose Metabolism in Aging
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