Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity
Recruitment status was Recruiting
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Purpose
The combination of high blood pressure and having central obesity is an increasing important factor for heart disease in men and women. It can also lead to the early development of hardening of the arteries and increased risk of a stroke. This study will analyze patients' genetic make up to identify who may be at greater risk for heart disease and strokes in relationship to high blood pressure and central obesity.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome X |
Drug: Eplerenone Drug: Ramipril |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity |
- Secreted factors from adipocytes have autocrine, paracrine and endocrine effects that have a deleterious effect on the fibrinolytic system, either by enhancing PAI-1 production or impairing endothelial t-PA release [ Time Frame: 10-Week period ] [ Designated as safety issue: No ]
- This study will analyze patients' genetic make up to identify who may be at greater risk for heart disease and strokes in relationship to high blood pressure and central obesity. [ Time Frame: 10-weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Treatment A
Eplerenone (study drug)
|
Drug: Eplerenone
5 mg x 1 week followed by 10 mg x 9 weeks.
Other Name: Inspra
|
|
Active Comparator: Treatment B
Ramipril
|
Drug: Ramipril
Ramipril 5mg qd x 1 week f/b Ramipril qd x 9 weeks.
|
Detailed Description:
Obesity is an increasingly important risk factor for cardiovascular disease in men and women and is associated with the premature development of atherosclerosis, and increased risk of stroke. A classical perspective of cardiovascular risk does not adequately explain all of the cardiovascular events associated with obesity. Elevated plasma levels of plasminogen activator inhibitor type I (PAI-1) are one of the biochemical hallmarks for obesity and likely contribute the increased risk of atherothrombotic events in patients with obesity. The central hypothesis of this proposal is that the increased risk of atherothrombotic events in patients with obesity. The central hypothesis of this proposal is that vascular PAI-1 excess promotes the development of intravascular thrombosis. We will test the hypothesis that secreted factors from adipocytes have autocrine, paracrine and endocrine effects that have a deleterious effect on the fibrinolytic system, either by enhancing PAI-1 production or impairing endothelial t-PA release. From a public health perspective, there is no greater threat to America's cardiovascular health than the epidemic of obesity. It is anticipated that this study will provide new insights nto the molecular mechanisms that contribute to the development of fibrinolytic dysfunction and cardiovascular disease in obesity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or females between the ages of 18 to 65 years of age.
- Documented diagnosis for the metabolic syndrome:
- Subjects with hypertension (SP>130mmHg)
- Subjects with central obesity (females waist >35"; males waist >40")
- Subjects with dyslipidemia (HDL <40mg/dl, triglycerides > 150 mg/dl)
- Subjects who are insulin resistance (fasting glucose >100mg/dl)
Exclusion Criteria:
- Subjects who smoke
- Women who are pregnant (confirmed by urine beta-HCG).
- Women who are breast feeding
Subjects with documentation of the following health risk:
- Subjects with serum creatinine >2.0 mg/dl (males), >1.8 mg/dl (females)
- Subjects whose creatinine clearance < 50 mls/min
- Subjects with serum potassium >5.5mEql
- Subjects with Type 2 diabetes with microalbuminuria (spot urine protein/creatinine ration >0.2)
- Subjects who are currently taking the following medications:
- Warfarin
Contacts and Locations| Contact: James AS Muldowney, III, MD | 615-936-1719 | james.muldowney@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: James AS Muldowney, III, MD 615-936-1750 james.muldowney@vanderbilt.edu | |
| Principal Investigator: | James AS Muldowney, MD | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | James A.S. Muldowney III, MD, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00608465 History of Changes |
| Other Study ID Numbers: | 060369, 060369 |
| Study First Received: | January 22, 2008 |
| Last Updated: | April 10, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vanderbilt University:
|
Fibrolytic Dysfunction Obesity PAI-1 |
Additional relevant MeSH terms:
|
Obesity Metabolic Syndrome X Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Ramipril Eplerenone |
Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Aldosterone Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013