Metabolic SyndromeNCT00750308
Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi and PE5i
A study testing Ramipril and Tadalafil in people with Metabolic Syndrome, run by Vanderbilt University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Ramipril and Tadalafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to May 2009
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Ramipril, Tadalafil, placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
Also called Altace
Ramipril 10 mg per day for three weeks
TadalafilDrug
Also called Cialis
tadalafil 10 mg every other day for three weeks
placeboDrug
Also called matching ramipril
placebo matching ramipril
placeboDrug
Also called matching tadalfil
placebo matching tadalafil
| Study group | Role | What they receive |
|---|---|---|
| tadalafil, ramapril, combo, placebo | Active comparator | placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril + tadalafil, washout, placebo+placebo for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| ramipril, tadalafil, placebo, combo | Active comparator | placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| combo, placebo, tadalafil, ramipril | Active comparator | ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| placebo, combo, ramipril, tadalafil | Active comparator | placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| tadalafil, placebo, ramipril, combo | Active comparator | placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| ramipril, combo, tadalfil, placebo | Active comparator | placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| combo, ramipril, placebo, tadalafil | Active comparator | ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| placebo, tadalafil, combo, ramipril | Active comparator | placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| tadalafil, combo, placebo, ramipril | Active comparator | placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| ramipril, placebo, combo, tadalafil | Active comparator | placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| combo, tadalafil, ramipril, placebo | Active comparator | ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
| placebo, ramipril, tadalafil, combo | Active comparator | placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks Receives: Drug: Ramipril; Drug: Tadalafil; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta Cell Function
Beta cell function as measured during a frequently sampled IV glucose tolerance test
Measured: 3 hours
Insulin Sensitivity
As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startDec 2006
- Primary completionJan 2009
- Study completionMay 2009
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.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Nancy J. Brown, Vanderbilt University
- Investigators
- Nancy J Brown, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750308
- Sponsor's protocol ID
- 060198
- Status last verified
- Dec 2014
- First submitted
- 5 Sep 2008
- Last updated
- 18 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi
- ClinicalTrials.gov ID
- NCT00750308
- Acronym / sponsor ID
- 060198
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Dec 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Posted 12 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| tadalafil, ramapril, combo, placebo | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboplacebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril + tadalafil, washout, placebo+placebo for three weeks |
| ramipril, tadalafil, placebo, combo | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboplacebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks |
| combo, placebo, tadalafil, ramipril | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks |
| placebo, combo, ramipril, tadalafil | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboplacebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks |
| tadalafil, placebo, ramipril, combo | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboplacebo+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks |
| ramipril, combo, tadalfil, placebo | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboplacebo+ramipril for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo for three weeks |
| combo, ramipril, placebo, tadalafil | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, placebo+tadalafil for three weeks |
| placebo, tadalafil, combo, ramipril | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboplacebo+placebo for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+ramipril for three weeks |
| tadalafil, combo, placebo, ramipril | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboplacebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+placebo for three weeks, washout, placebo+ramipril for three weeks |
| ramipril, placebo, combo, tadalafil | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboplacebo+ramipril for three weeks, washout, placebo+placebo for three weeks, washout, ramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks |
| combo, tadalafil, ramipril, placebo | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboramipril+tadalafil for three weeks, washout, placebo+tadalafil for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+placebo for three weeks |
| placebo, ramipril, tadalafil, combo | Active comparator | Drug: Ramipril, Drug: Tadalafil, Drug: placeboplacebo+placebo for three weeks, washout, placebo+ramipril for three weeks, washout, placebo+tadalafil for three weeks, washout, ramipril+tadalafil for three weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ambulatory subjects, 18 to 70 years of age, inclusive
- For female subjects, the following conditions must be met:
- Metabolic syndrome as defined by 3 or more of the following:
Key exclusion criteria (23 listed)
- 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
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 |
|---|---|---|
| RamiprilAlso: AltaceRamipril 10 mg per day for three weeks | Drug | combo, placebo, tadalafil, ramipril, combo, ramipril, placebo, tadalafil, combo, tadalafil, ramipril, placebo, placebo, combo, ramipril, tadalafil, placebo, ramipril, tadalafil, combo, placebo, tadalafil, combo, ramipril, ramipril, combo, tadalfil, placebo, ramipril, placebo, combo, tadalafil, ramipril, tadalafil, placebo, combo, tadalafil, combo, placebo, ramipril, tadalafil, placebo, ramipril, combo, tadalafil, ramapril, combo, placebo |
| TadalafilAlso: Cialistadalafil 10 mg every other day for three weeks | Drug | combo, placebo, tadalafil, ramipril, combo, ramipril, placebo, tadalafil, combo, tadalafil, ramipril, placebo, placebo, combo, ramipril, tadalafil, placebo, ramipril, tadalafil, combo, placebo, tadalafil, combo, ramipril, ramipril, combo, tadalfil, placebo, ramipril, placebo, combo, tadalafil, ramipril, tadalafil, placebo, combo, tadalafil, combo, placebo, ramipril, tadalafil, placebo, ramipril, combo, tadalafil, ramapril, combo, placebo |
| placeboAlso: matching ramiprilplacebo matching ramipril | Drug | combo, placebo, tadalafil, ramipril, combo, ramipril, placebo, tadalafil, combo, tadalafil, ramipril, placebo, placebo, combo, ramipril, tadalafil, placebo, ramipril, tadalafil, combo, placebo, tadalafil, combo, ramipril, ramipril, combo, tadalfil, placebo, ramipril, placebo, combo, tadalafil, ramipril, tadalafil, placebo, combo, tadalafil, combo, placebo, ramipril, tadalafil, placebo, ramipril, combo, tadalafil, ramapril, combo, placebo |
| placeboAlso: matching tadalfilplacebo matching tadalafil | Drug | combo, placebo, tadalafil, ramipril, combo, ramipril, placebo, tadalafil, combo, tadalafil, ramipril, placebo, placebo, combo, ramipril, tadalafil, placebo, ramipril, tadalafil, combo, placebo, tadalafil, combo, ramipril, ramipril, combo, tadalfil, placebo, ramipril, placebo, combo, tadalafil, ramipril, tadalafil, placebo, combo, tadalafil, combo, placebo, ramipril, tadalafil, placebo, ramipril, combo, tadalafil, ramapril, combo, placebo |
Primary outcome
Beta Cell Function
Time frame: 3 hours
Beta cell function as measured during a frequently sampled IV glucose tolerance test
Insulin Sensitivity
Time frame: three weeks
As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy J Brown, M.D. principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Ramipril and Tadalafil in people with Metabolic Syndrome, run by Vanderbilt University.
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 11 inclusion and 23 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2010). 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?
Beta Cell Function (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2014.