Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis
Phase 4
Terminated
- Conditions
- Impaired Glucose Tolerance
- Interventions
- Registration Number
- NCT01409993
- Lead Sponsor
- Vanderbilt University
- Brief Summary
The purpose of this study is to determine the effect of chronic PDE5 inhibitor therapy on glucose metabolism in persons with prediabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Aim 2 Euglycemic clamp matching placebo p.o. tid sildenafil Aim 1 Hyperglycemic clamp sildenafil 25 mg p.o. tid placebo Aim 1 Placebo matching placebo p.o. tid sildenafil Aim 2 Euglycemic clamp sildenafil 25 mg p.o. tid placebo Aim 2 Placebo matching placebo p.o. tid placebo Aim 1 Hyperglycemic clamp matching placebo p.o. tid sildenafil Aim 2 Sildenafil sildenafil 25 mg p.o. tid sildenafil Aim 1 Sildenafil sildenafil 25 mg p.o. tid
- Primary Outcome Measures
Name Time Method Index of Tissue Sensitivity to Insulin 2.5 hours after 3 months of therapy in the group of subjects undergoing hyperglycemic clamp (Aim 1), calculated by dividing the average glucose infusion rate during the last hour of the clamp by the average plasma insulin concentration during the same interval
Insulin Secretion 2.5 hours after 3 months of therapy in the group of subjects undergoing hyperglycemic clamp (Aim 1)
Glucose Infusion Rate 2.5 hours after 3 months of therapy In the group of subjects undergoing euglycemic clamp (Aim 2)
- Secondary Outcome Measures
Name Time Method Blood Pressure 3 months Systolic blood pressure
Fasting Plasma Glucose 3 months
Trial Locations
- Locations (1)
Vanderbilt University
🇺🇸Nashville, Tennessee, United States