NCT01409993

Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of chronic PDE5 inhibitor therapy on glucose metabolism in persons with prediabetes.

Conditions

• Impaired Glucose Tolerance

Interventions

Type	Name	Description
DRUG	Sildenafil	Sildenafil 25 mg by mouth three times a day for three months
DRUG	Placebo	Matching placebo three times a day for three months
DIAGNOSTIC_TEST	Hyperglycemic clamp	Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil or placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
DIAGNOSTIC_TEST	Euglycemic clamp	Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil or placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.

Timeline

• Start date: 2011-08-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2011-08-04
• Last updated: 2017-04-17
• Results posted: 2017-04-17

Locations

1 site across 1 country: United States