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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01409993
First received: July 11, 2011
Last updated: April 30, 2014
Last verified: April 2014

July 11, 2011
April 30, 2014
August 2011
April 2016   (final data collection date for primary outcome measure)
  • insulin secretion [ Time Frame: 2.5 hours before and after 3 months of therapy ] [ Designated as safety issue: No ]
    in the subjects undergoing hyperglycemic clamp to assess glucose-stimulated insulin secretion
  • glucose infusion rate [ Time Frame: 2.5 hours before and after 3 months of therapy ] [ Designated as safety issue: No ]
    In the group of subjects undergoing euglycemic clamp
  • plasma insulin [ Time Frame: 2.5 hours ] [ Designated as safety issue: Yes ]
  • plasma glucose [ Time Frame: 2.5 hours ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01409993 on ClinicalTrials.gov Archive Site
  • fasting plasma glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis
Not Provided

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Impaired Glucose Tolerance
Drug: Administration of Sildenafil or Placebo
Subjects with IGF will have a baseline hyperglycemic or a euglycemic clamp and then receive sildenafil or placebo for 3 months. Another hyperglycemic or euglycemic clamp will be preformed followed by another 3 months of drug and an oral glucose tolerance test.
  • Experimental: sildenafil
    Intervention: Drug: Administration of Sildenafil or Placebo
  • Placebo Comparator: placebo
    Intervention: Drug: Administration of Sildenafil or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
Not Provided
April 2016   (final data collection date for primary outcome measure)

Inclusion criteria:

Age > 18 years and BMI > 25 kg/M2 (> 23 kg/M2 among Asian Americans) Elevated fasting plasma glucose (100-125 mg/dL) IGT (2 hour plasma glucose 140-199 mg/dL) OR metabolic syndrome and/or hemoglobin A1c 5.7-6.4%

Exclusion criteria:

  • Diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dL or greater, a two hour plasma glucose of 200 mg/dL or greater, or the use of anti-diabetic medication.
  • The use of nitrates or any disease that might require the use of nitrates.
  • The use of any potent CYP3A4 inhibitor.
  • subjects who have participated in a weight-reduction program during the last 6 month or whose weight has increased or decreased more than 2 kg over the preceding 6 months.
  • Pregnancy. Women of child-bearing potential will be required to have undergone tubal ligation or to be using barrier methods of birth control.
  • Breast-feeding.
  • Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy.
  • Treatment with anticoagulants.
  • Treatment with metformin.
  • History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack.
  • History or presence of immunological or hematological disorders.
  • Diagnosis of asthma.
  • Clinically significant gastrointestinal impairment that could interfere with drug absorption.
  • Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino.

transaminase [ALT] >1.5 x upper limit of normal range)

  • Impaired renal function (serum creatinine >1.5 mg/dl).
  • Hematocrit <35%.
  • Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult.
  • Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in

    1 month).

  • Treatment with lithium salts.
  • History of alcohol or drug abuse.
  • Treatment with any investigational drug in the 1 month preceding the study.
  • Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study.
  • Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Both
18 Years and older
No
Contact: Loretta Byrne, RN 615-322-2105 loretta.byrne@vanderbilt.edu
Contact: Cyndia Shibao, MD 615-936-4584 Cyndya.shibao@vanderbilt.edu
United States
 
NCT01409993
110206
Yes
Nancy J. Brown, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Nancy J Brown, MD Vanderbilt University
Vanderbilt University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP