Metabolic SyndromePhase 1/2NCT01334554
Study of Sildenafil Citrate on Insulin Resistance in African American
A Phase 1/2 study testing Sildenafil in people with Metabolic Syndrome and Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sildenafil Citrate on Insulin Resistance and Endothelial Function in Obese African American Women
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.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Sildenafil, Placebo
- Keywords
- African American, Women, Metabolic Syndrome, Endothelial function, Sildenafil citrate
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Revatio
20 mg three times a day.
PlaceboDrug
No active drug
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | Sildenafil 20 mg three times a day Receives: Drug: Sildenafil |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test
Measured: Insulin sensitivity measured at baseline and 4 weeks after the intervention
Secondary outcomes (1)
Endothelial Function
Endothelial function was measured with flow mediated dilation, percent change
Measured: Difference between FMD at baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Pfizer
- Responsible party
- Principal investigator, Cyndya Shibao, Vanderbilt University Medical Center
- Investigators
- Cyndya Shibao, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334554
- Sponsor's protocol ID
- 100713
- Other IDs
- K23HL103976
- Status last verified
- Feb 2017
- First submitted
- 11 Apr 2011
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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):e002388. doi: 10.1161/JAHA.115.002388.
PubMed 26541392
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sildenafil Citrate on Insulin Resistance and Endothelial Function in Obese African American Women
- ClinicalTrials.gov ID
- NCT01334554
- Acronym / sponsor ID
- 100713
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- African American, Women, Metabolic Syndrome, Endothelial function, Sildenafil citrate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Pfizer
- Study start
- Apr 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Posted 10 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: SildenafilSildenafil 20 mg three times a day |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilAlso: Revatio20 mg three times a day. | Drug | Sildenafil |
| PlaceboNo active drug | Drug | Placebo |
Primary outcome
Insulin Sensitivity
Time frame: Insulin sensitivity measured at baseline and 4 weeks after the intervention
insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test
1 secondary outcome
Endothelial Function
Time frame: Difference between FMD at baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26541392Marinos 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):e002388. doi: 10.1161/JAHA.115.002388.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyndya Shibao, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sildenafil in people with Metabolic Syndrome and Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Insulin sensitivity measured at baseline and 4 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.