Exercise Training and Glucose Metabolism in Aging

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Aging, Angiogenesis and Metabolic Responses to Aerobic Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701051
• Other study ID #: CDA-2-039-08S
• Secondary ID: H-279405P30AG028
• Status: Completed
• Phase: N/A
• First received: June 18, 2008
• Last updated: March 23, 2015
• Start date: October 2006
• Est. completion date: June 2012

Study information

• Verified date: March 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance (Prediabetes)
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Aerobic exercise training
24 weeks of aerobic exercise training: 3 times per week, 60 minutes per session, at 70% of maximal aerobic capacity
• Detraining (cessation of exercise)
Cessation of exercise for 2 weeks

Locations

Country	Name	City	State
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	National Institute on Aging (NIA), National Institutes of Health (NIH), University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Glucose Utilization	Insulin-stimulated glucose uptake	baseline	No
Primary	Glucose Utilization (Pre/Post Intervention)	Insulin-stimulated glucose uptake	baseline, 24 weeks, 26 weeks	No
Primary	Baseline Skeletal Muscle Capillarization		baseline	No
Primary	Skeletal Muscle Capillarization (Pre/Post Intervention)		baseline, 24 weeks, 26 weeks	No
Secondary	Baseline 2-hour Postprandial Glucose		baseline	No
Secondary	2-hr Post-prandial Plasma Glucose Level		baseline, 24 weeks, 26 weeks	No
Secondary	Baseline Cardiorespiratory Fitness	maximal oxygen consumption	baseline	No
Secondary	Cardiorespiratory Fitness	Maximal oxygen consumption	baseline, 24 weeks, 26 weeks	No
Secondary	Body Composition (%Fat)		baseline, 24 weeks	No