Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity

July 13, 2017 updated by: James Muldowney, Vanderbilt University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment A
Eplerenone (study drug)
Drug: Eplerenone
5 mg x 1 week followed by 10 mg x 9 weeks.
Other Names:
  • Inspra
Active Comparator: Treatment B
Ramipril
Drug: Ramipril
Ramipril 5mg qd x 1 week f/b Ramipril qd x 9 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10-Week period
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
10-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: James AS Muldowney, MD, 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 (Actual)

May 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060369

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.

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