CompletedNot Applicable

Influence of Endothelial Function on Central and Peripheral Causes Of Exercise Impairment in Type 2 Diabetes

United States47 participantsStarted 2008-05

Plain-language summary

This study will evaluate the effects of impaired blood flow regulation on exercise. It will also determine whether the effects are more important in the heart or in the skeletal muscle tissue during exercise. In addition, this study will decide whether temporarily reversing these problems will improve blood flow control, improve heart and muscle tissue function and help improve exercise capacity in person with type 2 diabetes. This study will do so using two methods: (1) by giving vitamin C intravenously (IV) and (2) a three month exercise training program. Up to 100 subjects will be enrolled in this study.

Who can participate

Age range30 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women with uncomplicated Type 2 Diabetes * Healthy men and women without Type 2 Diabetes * Patients with Type 2 Diabetes may be taking metformin or sulfonylurea drugs to treat diabetes * Persons with history of hypercholesteremia if controlled with statins and/or diet * Patients who are moderately overweight (BMI 25-37.5) * Must be sedentary (defined as regular exercise \< 2 times a week at a low to moderate level). * Patients with Hemoglobin A1c (HBA1C) \<8% * Patients between the ages of 30 to 55 years * Premenopausal women. * Former smokers who have quit smoking for at least one year * Absence of comorbid conditions * Mild neuropathy is O.K. as long as it will not hamper exercise performance. * Resting systolic blood pressure (SBP) \< 140, Resting diastolic blood pressure (DBP) \< 90 * Total Cholesterol \< 205 Triglycerides \< 250 low density lipoprotein (LDL) \< 130 * Control subjects with a normal A1C and fasting glucose Exclusion Criteria: * People with T2DM taking oral medications, other than metformin or sulfonylurea drugs to control their diabetes. * Persons treated with insulin will be excluded * People who are currently smoking or have not quit for at least one year * Controls who have immediate family history of T2DM * Peri-menopausal or post-menopausal women. * Peripheral neuropathy * Total cholesterol \> 205 * Regional wall motion abnormalities * LV wall thickness ≥1.1 cm * Decreased contractility (fractional shortening \<30%) * …

What they're measuring

Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training

Timeframe: 7 months; Measures are made at rest and after exercise for baseline, at rest and after infusion for Vitamin C administration, and at rest and after exercise following the exercise training

Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training

Timeframe: 7 months; Measures are made at rest for baseline, at rest for Vitamin C administration, and at rest following the exercise training

Trial details

NCT IDNCT00786019

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-10

Results submitted2018-02-27

View on ClinicalTrials.gov More Type 2 Diabetes trials