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

NCT ID: NCT00742066

Last Updated: 2011-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-07-31

Brief Summary

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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?

Detailed Description

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Conditions

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Hypertension Insulin Resistance Microcirculation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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I

Irbesartan

Group Type EXPERIMENTAL

Irbesartan

Intervention Type DRUG

Single dose 600mg orally

II

Felodipine

Group Type ACTIVE_COMPARATOR

Felodipine

Intervention Type DRUG

single dose 10mg Felodipine ER

III

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose tablet orally

Interventions

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Irbesartan

Single dose 600mg orally

Intervention Type DRUG

Felodipine

single dose 10mg Felodipine ER

Intervention Type DRUG

Placebo

Single dose tablet orally

Intervention Type DRUG

Other Intervention Names

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Aprovel C09CA04 Plendil C08CA02

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Maastricht

Principal Investigators

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CDA Stehouwer, Prof.

Role: STUDY_CHAIR

Univeristy Hospital Maastricht

Locations

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University Hospital Maastricht

Maastricht, P.O. Box 5800, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEC 07-2-115

Identifier Type: -

Identifier Source: org_study_id

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