Role of AT1-Receptor Blockers in Insulin-Induced Vasodilation. - Full Text View

Sponsored by:	Maastricht University Medical Center
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00742066

Purpose

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?

Condition	Intervention
Hypertension Insulin Resistance Microcirculation	Drug: Irbesartan Drug: Felodipine Drug: Placebo

Genetics Home Reference related topics: ataxia-telangiectasia

MedlinePlus related topics: Ataxia Telangiectasia High Blood Pressure

Drug Information available for: Insulin Irbesartan Angiotensin II Angiotensin II, ile(5)- Felodipine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Official Title:	Insulin-Induced Microvascular Activity in Patients With Essential Hypertension: a Possible Role for Angiotensin II AT1-Receptor Blockers.

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

functional recruitment of capillaries in the skin [ Time Frame: July 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

perfused capillary density in the nailfold [ Time Frame: July 2009 ] [ Designated as safety issue: No ]
Endothelium- (in)dependent vasodilatation of finger skin microcirculation [ Time Frame: July 2009 ] [ Designated as safety issue: No ]
Density of arterioles, capillaries and venules in the bulbar conjunctiva. [ Time Frame: July 2009 ] [ Designated as safety issue: No ]
Diameter of arterioles and venules in the bulbar conjunctiva [ Time Frame: July 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	March 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Irbesartan	Drug: Irbesartan Single dose 600mg orally
II: Active Comparator Felodipine	Drug: Felodipine single dose 10mg Felodipine ER
III: Placebo Comparator Placebo	Drug: Placebo Single dose tablet orally

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

hypertensive subjects:

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

normotensive subjects:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742066

Contacts

Contact: A.M. Jonk, MSc	+31 43 3881432	a.jonk@intmed.unimaas.nl
Contact: A.J.H.M. Houben, Dr.	+31 43 3882122	b.houben@intmed.unimaas.nl

Locations

Netherlands, P.O. Box 5800
University Hospital Maastricht	Recruiting
Maastricht, P.O. Box 5800, Netherlands, 6202 AZ
Contact: A.M. Jonk, MSc +31 43 3881432 a.jonk@intmed.unimaas.nl
Contact: A.J.H.M. Houben, Dr. +31 43 3882122 b.houben@intmed.unimaas.nl

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Study Chair:

CDA Stehouwer, Prof.

Univeristy Hospital Maastricht

More Information

Responsible Party:	University Hospital Maastricht ( Prof. CDA Stehouwer )
Study ID Numbers:	MEC 07-2-115
Study First Received:	August 26, 2008
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00742066
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

Hypertension
Insulin resistance
Microcirculation
Angiotensin II receptor blocker

Study placed in the following topic categories:

Metabolic Diseases
Ataxia-Telangiectasia
Vascular Diseases
Irbesartan
Angiotensin II
Insulin
Calcium, Dietary
Hyperinsulinism

Essential hypertension
Ataxia Telangiectasia
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder
Felodipine
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vasoconstrictor Agents

Calcium Channel Blockers
Cardiovascular Diseases
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009