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

NCT01409993 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2017-04-17

Study results available
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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

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.

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Nancy J Brown, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409993 on ClinicalTrials.gov