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

This study has been terminated.
(Aim 1 was stopped by DSMB. Aim 2 was stopped due to ending of funding.)
Sponsor:
Information provided by (Responsible Party):
Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01409993
First received: July 11, 2011
Last updated: March 3, 2017
Last verified: March 2017
Results First Received: December 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Basic Science
Condition: Impaired Glucose Tolerance
Interventions: Drug: Sildenafil
Drug: Placebo
Diagnostic Test: Hyperglycemic clamp
Diagnostic Test: Euglycemic clamp

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sildenafil Aim 1

sildenafil 25 mg p.o. tid

Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test.

Placebo Aim 1

matching placebo p.o. tid

Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.

Sildenafil Aim 2 Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive sildenafil for 3 months. Another euglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test.
Placebo Aim 2 Administration of Placebo: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.

Participant Flow:   Overall Study
    Sildenafil Aim 1   Placebo Aim 1   Sildenafil Aim 2   Placebo Aim 2
STARTED   25   26   14   13 
COMPLETED   21   21   11   8 
NOT COMPLETED   4   5   3   5 
Adverse Event                4                4                3                1 
Withdrawal by Subject                0                0                0                4 
Lost to Follow-up                0                1                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sildenafil

sildenafil 25 mg p.o. tid

Administration of sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.

Placebo

matching placebo p.o. tid

Administration of placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil or placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.

Total Total of all reporting groups

Baseline Measures
   Sildenafil   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   39   78 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.4  (10.6)   51.0  (10.6)   49.58  (10.80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  61.5%      26  66.7%      50  64.1% 
Male      15  38.5%      13  33.3%      28  35.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   2.6%      0   0.0%      1   1.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      9  23.1%      7  17.9%      16  20.5% 
White      29  74.4%      32  82.1%      61  78.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   39   39   78 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Insulin Secretion   [ Time Frame: 2.5 hours after 3 months of therapy ]

2.  Primary:   Index of Tissue Sensitivity to Insulin   [ Time Frame: 2.5 hours after 3 months of therapy ]

3.  Primary:   Glucose Infusion Rate   [ Time Frame: 2.5 hours after 3 months of therapy ]

4.  Secondary:   Fasting Plasma Glucose   [ Time Frame: 3 months ]

5.  Secondary:   Blood Pressure   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nancy J. Brown, M.D., Principal Investigator
Organization: Vanderbilt University Medical Center
phone: 6153438701
e-mail: nancy.j.brown@vanderbilt.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nancy J. Brown, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01409993     History of Changes
Other Study ID Numbers: 110206
Study First Received: July 11, 2011
Results First Received: December 7, 2016
Last Updated: March 3, 2017