Defining Strategies for Improving Endothelial and Fibrinolytic Dysfunction in Obesity

NCT00608465 | Terminated Phase 4 Results DMC

• 1 other identifier: 060369
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome X

Keywords

Fibrolytic Dysfunction; Obesity; PAI-1

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  10-weeks

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

Eplerenone (study drug)

Drug: Eplerenone

Treatment B

ACTIVE COMPARATOR

Ramipril

Drug: Ramipril

Interventions

Eplerenone DRUG

5 mg x 1 week followed by 10 mg x 9 weeks.

Also known as: Inspra

Treatment A

Ramipril DRUG

Ramipril 5mg qd x 1 week f/b Ramipril qd x 9 weeks.

Treatment B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Interventions

Eplerenone; Ramipril

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: James Muldowney
• Organization: Vanderbilt University Medical Center

james.muldowney@vanderbilt.edu

615-936-1720

Study Officials

• James AS Muldowney, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 6, 2008
• Study Start: May 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2011
• Last Updated: August 11, 2017
• Results First Posted: May 1, 2017

Record last verified: 2017-07

Locations

US (1)