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| ID | Type | Description | Link |
|---|---|---|---|
| H-27940 | Other Identifier | IRB | |
| 5P30AG028747-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Maryland | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Older adults, normal glucose tolerance |
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| Arm 2 | Experimental | Older adults, impaired glucose tolerance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise training | Behavioral | 24 weeks of aerobic exercise training: 3 times per week, 60 minutes per session, at 70% of maximal aerobic capacity |
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline Glucose Utilization | Insulin-stimulated glucose uptake | baseline |
| Glucose Utilization (Pre/Post Intervention) | Insulin-stimulated glucose uptake | baseline, 24 weeks, 26 weeks |
| Baseline Skeletal Muscle Capillarization | baseline | |
| Skeletal Muscle Capillarization (Pre/Post Intervention) | baseline, 24 weeks, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline 2-hour Postprandial Glucose | baseline | |
| 2-hr Post-prandial Plasma Glucose Level | baseline, 24 weeks, 26 weeks | |
| Baseline Cardiorespiratory Fitness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J. Prior, PhD | VA Maryland Health Care System, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Maryland Health Care System, Baltimore | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26068543 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Older Adults | |
| FG001 | Older Adults - Normal Glucose Tolerance | Normal Glucose Tolerance. Participants assigned to group after Period 1: Screening |
| FG002 | Older Adults - Impaired Glucose Tolerance | Impaired Glucose Tolerance. Participants assigned to group after Period 1: Screening |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
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| Exercise Intervention |
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| Detraining Intervention (Optional) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Older Adults - Normal Glucose Tolerance | Normal Glucose Tolerance |
| BG001 | Older Adults - Impaired Glucose Tolerance | Impaired Glucose Tolerance |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline Glucose Utilization | Insulin-stimulated glucose uptake | Posted | Mean | Standard Error | µmol/kgFFM/pmol insulin/min | baseline |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Older Adults | Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm); thus, data are reported for the entire group of participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Fall due to distraction while walking |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J. Prior, PhD | Baltimore VA Medical Center | 410-605-7000 | 4129 | steven.prior@va.gov |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Detraining (cessation of exercise) | Behavioral | Cessation of exercise for 2 weeks |
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maximal oxygen consumption |
| baseline |
| Cardiorespiratory Fitness | Maximal oxygen consumption | baseline, 24 weeks, 26 weeks |
| Body Composition (%Fat) | baseline, 24 weeks |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Baseline 2-hour Postprandial Glucose | Posted | Mean | Standard Error | mg/dl | baseline |
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| Primary | Glucose Utilization (Pre/Post Intervention) | Insulin-stimulated glucose uptake | Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants. | Posted | Mean | Standard Error | µmol/kgFFM/pmol insulin/min | baseline, 24 weeks, 26 weeks |
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| Secondary | 2-hr Post-prandial Plasma Glucose Level | Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants. | Posted | Mean | Standard Error | mg/dL | baseline, 24 weeks, 26 weeks |
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| Secondary | Baseline Cardiorespiratory Fitness | maximal oxygen consumption | Posted | Mean | Standard Error | L/min | baseline |
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| Primary | Baseline Skeletal Muscle Capillarization | Posted | Mean | Standard Error | capillaries/mm2 | baseline |
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| Primary | Skeletal Muscle Capillarization (Pre/Post Intervention) | Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants. | Posted | Mean | Standard Error | capillaries/mm2 | baseline, 24 weeks, 26 weeks |
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| Secondary | Cardiorespiratory Fitness | Maximal oxygen consumption | Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants. | Posted | Mean | Standard Error | L/Min | baseline, 24 weeks, 26 weeks |
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| Secondary | Body Composition (%Fat) | Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants. | Posted | Mean | Standard Error | percentage of fat | baseline, 24 weeks |
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| 0 |
| 90 |
| 1 |
| 90 |
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| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
| Title | Measurements |
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