NCT00780481

Brief Summary

T-PA release is impaired in obese subjects. In order to have a better mechanistic understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation, Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

July 14, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

4 years

First QC Date

October 24, 2008

Results QC Date

March 16, 2017

Last Update Submit

July 13, 2017

Conditions

Obesity

Keywords

ObesityEndothelial FunctionFibrinolytic BalanceBaseline

Outcome Measures

Primary Outcomes (1)

  • Peak t-PA Release

    tPA Release

    Single Study day

Secondary Outcomes (3)

  • Peak FMD

    Single Study Day

  • Radial Artery Elasticity

    Single Study Visit

  • Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.

    Single Study Day

Study Arms (1)

Bradykinin

EXPERIMENTAL

Patients will have flow mediated vasodilation and radial artery tonometry performed. They will then receive 0, 10, 20, 40 ng/100cc/min of intrabrachial bradykinin. Strain gauge plethysmography and blood sampling at each dose will be done to evaluate t-PA release. Blood will also be drawn for other biomarkers.

Drug: Bradykinin

Interventions

BradykininDRUG

Intrabrachial - 0, 10, 20, 40 ng/100cc/min over 5 minutes at each dose.

Bradykinin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years and greater
  • Healthy

You may not qualify if:

  • PVC \< 30
  • Hypertensive subjects on ACE inhibitors
  • Pregnant or nursing mothers
  • Diabetic with HbA1C \> 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
  • Cholesterol \> 30 mg/dL above NCEP accepted level based on cardiac risk.
  • Triglycerides \> 200
  • Previously diagnosed obstructive coronary artery disease, myocardial infarction or left ventricular dysfunction (with or without a history of congestive heart failure)
  • Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
  • History of cerebrovascular disease
  • Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
  • Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
  • Angiotensin converting enzyme inhibitor use
  • Coagulopathy (INR ≥ 1.5, PTT ≥ 1.5 x control)
  • Other chronic medical illnesses at the discretion of the investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Bradykinin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

KininsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsNeuropeptidesOligopeptidesProteinsNerve Tissue ProteinsAutacoidsInflammation MediatorsBiological Factors

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
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2011

Study Completion

May 1, 2011

Last Updated

July 14, 2017

Results First Posted

July 14, 2017

Record last verified: 2017-07

Locations

US(1)