Study of Sildenafil Citrate on Insulin Resistance in African American

NCT01334554

Last updated date
Study Location
Vanderbilt University
Nashville, Tennessee, 37232, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metabolic Syndrome, Obesity
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Race will be self-defined, but only subjects who report both parents of the same race will be included.

- Age 18-60 years old.

- The investigators will recruit subjects with wide range of BMI 30-45 kg/m2.

- Subjects who have metabolic syndrome or who have a fasting insulin >13. The diagnosis include 3 of the following:

Fasting blood glucose of greater than 100 Triglyceride levels of greater than 150 HDL cholesterol of less than 50 in women Blood pressure of at least 130/85, or on blood pressure medicine Waist girth of more than 35 inches in women. Subjects of childbearing potential will be required to have a negative serum/urine pregnancy test. In addition, they will be asked to use a reliable contraceptive method prior to enrollment as determined by the PI (Dr. Cyndya Shibao).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Previous allergic reactions to any of the study medication (sildenafil) or inability
to take study medications as prescribed during the course of the study.


- Type 1 or 2 diabetes mellitus as defined by a fasting glucose of 126 mg/dl or greater.


- Use of antidiabetic medication (insulin, metformin, sulfonylurea, troglitazone)


- 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.


- Current smokers.


- Significant weight change >5% from baseline in the past three months.


- Pregnancy or breast-feeding.


- History of serious neurological disease such as cerebral hemorrhage stroke, transient
ischemic attack.


- History or presence of immunological or hematological disorders.


- Clinical significant gastrointestinal impairment that could interfere with drug
absorption.


- Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino
transaminase [ALT] >1.5X upper limit of normal range).


- Impaired renal function (estimated glomerular filtration rate (eGFR) of <60mL/min).


- 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.


- History of alcohol or drug abuse.


- 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.


- Patients must not be taking nitratest in any form (e.g., nitroglycerin, isosorbide
dinitrate, nitroprusside, and others) during this study


- Patients on alpha-blocking drugs (doxazosin, terazosin , or prazosin) will be excluded


- Patients on protease inhibitors (ritonavir and others) will be excluded

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Metabolic Syndrome, ObesityStudy of Sildenafil Citrate on Insulin Resistance in African American
NCT01334554
  1. Nashville, Tennessee
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Sildenafil Citrate on Insulin Resistance in African American
Official Title  ICMJE Effect of Sildenafil Citrate on Insulin Resistance and Endothelial Function in Obese African American Women
Brief Summary

Obesity has a greater detrimental impact on the health of African American women than on any other racial or gender group. Nearly 80% of African American women are overweight or obese in the United States. Hypertension and insulin resistance are more prevalent among African American women as compared to men and Caucasians. These conditions put them at increased risk for the development of diabetes mellitus and cardiovascular disease.

Recent studies have reported that a substance named Nitric Oxide (NO)may have some beneficial effect on how the body handles blood sugar and blood pressure. Of interest,some studies have shown that African Americans have decreased function of NO in their blood vessels.

In this study proposal the investigators will test if increasing NO function with a PDE-5 inhibitor (sildenafil citrate) will improve pre-diabetes and the health of the inner layer of the blood vessels in obese African American women.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Metabolic Syndrome
  • Obesity
Intervention  ICMJE
  • Drug: Sildenafil
    20 mg three times a day.
    Other Name: Revatio
  • Drug: Placebo
    No active drug
Study Arms  ICMJE
  • Experimental: Sildenafil
    Sildenafil 20 mg three times a day
    Intervention: Drug: Sildenafil
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: Placebo
Publications * Marinos A, Celedonio JE, Ramirez CE, Gottlieb J, Gamboa A, Hui N, Yu C, Stein CM, Biaggioni I, Shibao CA. Time-Course Analysis of Flow Mediated Dilation for the Evaluation of Endothelial Function After a High-Fat Meal in African Americans. J Am Heart Assoc. 2015 Nov 5;4(11). pii: e002388. doi: 10.1161/JAHA.115.002388.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2013)
46
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2011)
42
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Race will be self-defined, but only subjects who report both parents of the same race will be included.
  • Age 18-60 years old.
  • The investigators will recruit subjects with wide range of BMI 30-45 kg/m2.
  • Subjects who have metabolic syndrome or who have a fasting insulin >13. The diagnosis include 3 of the following:

Fasting blood glucose of greater than 100 Triglyceride levels of greater than 150 HDL cholesterol of less than 50 in women Blood pressure of at least 130/85, or on blood pressure medicine Waist girth of more than 35 inches in women. Subjects of childbearing potential will be required to have a negative serum/urine pregnancy test. In addition, they will be asked to use a reliable contraceptive method prior to enrollment as determined by the PI (Dr. Cyndya Shibao).

Exclusion Criteria:

  • Previous allergic reactions to any of the study medication (sildenafil) or inability to take study medications as prescribed during the course of the study.
  • Type 1 or 2 diabetes mellitus as defined by a fasting glucose of 126 mg/dl or greater.
  • Use of antidiabetic medication (insulin, metformin, sulfonylurea, troglitazone)
  • 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.
  • Current smokers.
  • Significant weight change >5% from baseline in the past three months.
  • Pregnancy or breast-feeding.
  • History of serious neurological disease such as cerebral hemorrhage stroke, transient ischemic attack.
  • History or presence of immunological or hematological disorders.
  • Clinical significant gastrointestinal impairment that could interfere with drug absorption.
  • Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino transaminase [ALT] >1.5X upper limit of normal range).
  • Impaired renal function (estimated glomerular filtration rate (eGFR) of <60mL/min).
  • 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.
  • History of alcohol or drug abuse.
  • 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.
  • Patients must not be taking nitratest in any form (e.g., nitroglycerin, isosorbide dinitrate, nitroprusside, and others) during this study
  • Patients on alpha-blocking drugs (doxazosin, terazosin , or prazosin) will be excluded
  • Patients on protease inhibitors (ritonavir and others) will be excluded
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01334554
Other Study ID Numbers  ICMJE 100713
K23HL103976 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Cyndya Shibao, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Cyndya Shibao, MDVanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date February 2017

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