N/A
N=47
Influence of Endothelial Function on Central and Peripheral Causes Of Exercise Impairment in Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00786019 ↗Enrolled (actual)
47
Serious AEs
4.3%
Results posted
Sep 2018
Primary outcome: Primary: Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training — -24; -20; -23; -21 percentage of change in length
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise program (Behavioral); Ascorbic Acid (Vitamin C) (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training |
-24; -20; -23; -21; -22; -22 | — |
| PRIMARY Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training |
65; 65; 67; 63; 61; 65 | — |
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.
Eligibility Criteria
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 205
- Regional wall motion abnormalities
- LV wall thickness ≥1.1 cm
- Decreased contractility (fractional shortening 140 mmHg at rest or >250 mmHg with exercise or diastolic pressure >90 mmHg at rest or >105 mmHg with exercise
- Persons with autonomic insufficiency, assessed by measuring variation in RR intervals with cycled breathing and by presence of a >20 mm fall in upright blood pressure without a change in heart rate
- Proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl
- Renal disease
Data sourced from ClinicalTrials.gov (NCT00786019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.