Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi and PE5i
December 8, 2014 updated by: Nancy J. Brown, Vanderbilt University
Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi
This study will measure the effect of the agent tadalafil on glucose and insulin homeostasis in people with metabolic syndrome in the presence and absence of an ACE inhibitor.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ambulatory subjects, 18 to 70 years of age, inclusive
For female subjects, the following conditions must be met:
- Postmenopausal status for at least 1 year,
- Status-post surgical sterilization, or
- If of childbearing potential, utilization of adequate birth control, and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day
Metabolic syndrome as defined by 3 or more of the following:
- Fasting plasma glucose of at least 100 mg/dL (5.5 mmol/L),
- Serum triglycerides of at least 150 mg/dL (1.7 mmol/L),
- Serum HDL cholesterol less than 40 mg/dL (1.04 mmol/L) in males and less than 50mg/dl (1.30mmol/L) in females,
- Blood pressure of at least 130/85 mmHg, or
- Waist girth of more than 102 cm in men or 88 cm in women
Exclusion criteria:
Subjects presenting with any of the following will not be included in the study:
- Diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dL or greater or the use of anti-diabetic medication
- Use of hormone replacement therapy
- Statin therapy
- In hypertensive subjects, a seated systolic blood pressure greater than 179 mmHg or a seated diastolic blood pressure greater than 110 mmHg
- Pregnancy
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: tadalafil, ramapril, combo, placebo
placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril + tadalafil, washout, placebo+placebo for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: ramipril, tadalafil, placebo, combo
placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: combo, placebo, tadalafil, ramipril
ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: placebo, combo, ramipril, tadalafil
placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: tadalafil, placebo, ramipril, combo
placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: ramipril, combo, tadalfil, placebo
placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: combo, ramipril, placebo, tadalafil
ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: placebo, tadalafil, combo, ramipril
placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: tadalafil, combo, placebo, ramipril
placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: ramipril, placebo, combo, tadalafil
placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: combo, tadalafil, ramipril, placebo
ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
|
Active Comparator: placebo, ramipril, tadalafil, combo
placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks
|
Ramipril 10 mg per day for three weeks
Other Names:
tadalafil 10 mg every other day for three weeks
Other Names:
placebo matching ramipril
Other Names:
placebo matching tadalafil
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beta Cell Function
Time Frame: 3 hours
|
Beta cell function as measured during a frequently sampled IV glucose tolerance test
|
3 hours
|
|
Insulin Sensitivity
Time Frame: three weeks
|
As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm
|
three weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy J Brown, M.D., Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
September 5, 2008
First Submitted That Met QC Criteria
September 9, 2008
First Posted (Estimate)
September 10, 2008
Study Record Updates
Last Update Posted (Estimate)
December 18, 2014
Last Update Submitted That Met QC Criteria
December 8, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Insulin Resistance
- Hyperinsulinism
- Metabolic Syndrome
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Phosphodiesterase Inhibitors
- Angiotensin-Converting Enzyme Inhibitors
- Phosphodiesterase 5 Inhibitors
- Tadalafil
- Ramipril
Other Study ID Numbers
- 060198
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.