Role of AT1-receptor Blockers in Insulin-induced Vasodilation.

March 16, 2011 updated by: Maastricht University Medical Center

Insulin-induced Microvascular Activity in Patients With Essential Hypertension: a Possible Role for Angiotensin II AT1-receptor Blockers.

In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2. Does blockade of the angiotensin II AT1-receptor impair the insulin-induced microvascular effects in normotensive control subjects?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

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

  • Netherlands
    • P.O. Box 5800
      • Maastricht, P.O. Box 5800, Netherlands, 6202 AZ
        • University Hospital Maastricht

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 to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

hypertensive subjects:

  1. 18-60 years
  2. Caucasian
  3. untreated hypertension >140/90mmHg.

normotensive subjects:

  1. 18-60 years
  2. Caucasian
  3. Blood pressure <140/90 mmHg.

Exclusion Criteria:

  1. Obesity (BMI>27kg/m2)
  2. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
  3. Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA
  4. Smoking
  5. Alcohol use >4U/day
  6. Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
  7. Pregnancy
  8. Wearing contact lenses

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: III
Placebo
Drug: Placebo
Single dose tablet orally
Experimental: I
Irbesartan
Drug: Irbesartan
Single dose 600mg orally
Other Names:
  • Aprovel C09CA04
Active Comparator: II
Felodipine
Drug: Felodipine
single dose 10mg Felodipine ER
Other Names:
  • Plendil C08CA02

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
functional recruitment of capillaries in the skin
Time Frame: July 2009
July 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
perfused capillary density in the nailfold
Time Frame: July 2009
July 2009
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Time Frame: July 2009
July 2009
Density of arterioles, capillaries and venules in the bulbar conjunctiva.
Time Frame: July 2009
July 2009
Diameter of arterioles and venules in the bulbar conjunctiva
Time Frame: July 2009
July 2009

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Investigators

  • Study Chair: CDA Stehouwer, Prof., Univeristy Hospital Maastricht

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

March 1, 2008

Primary Completion (Anticipated)

July 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimate)

August 27, 2008

Study Record Updates

Last Update Posted (Estimate)

March 17, 2011

Last Update Submitted That Met QC Criteria

March 16, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 07-2-115

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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