Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi and PE5i

Metabolic Syndrome Clinical Trial

Official title:

Renin Angiotensin Aldosterone System (RAAS) and Fibrinolysis in Humans: ACEi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750308
• Other study ID #: 060198
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: December 8, 2014
• Start date: December 2006
• Est. completion date: May 2009

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Ambulatory subjects, 18 to 70 years of age, inclusive

2. 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

3. 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:

1. 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

2. Use of hormone replacement therapy

3. Statin therapy

4. In hypertensive subjects, a seated systolic blood pressure greater than 179 mmHg or a seated diastolic blood pressure greater than 110 mmHg

5. Pregnancy

6. Breast-feeding

7. 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

8. Treatment with anticoagulants

9. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack

10. History or presence of immunological or hematological disorders

11. Diagnosis of asthma

12. Clinically significant gastrointestinal impairment that could interfere with drug absorption

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

14. Impaired renal function (serum creatinine > 1.5 mg/dl)

15. Hematocrit < 35%

16. 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

17. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)

18. Treatment with lithium salts

19. History of alcohol or drug abuse

20. Treatment with any investigational drug in the 1 month preceding the study

21. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study

22. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Ramipril
Ramipril 10 mg per day for three weeks
• Tadalafil
tadalafil 10 mg every other day for three weeks
• placebo
placebo matching ramipril
• placebo
placebo matching tadalafil

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta Cell Function	Beta cell function as measured during a frequently sampled IV glucose tolerance test	3 hours	No
Primary	Insulin Sensitivity	As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm	three weeks	No