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

Sponsor:	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

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.

Resource links provided by NLM:

Genetics Home Reference related topics: ataxia-telangiectasia

MedlinePlus related topics: Ataxia Telangiectasia High Blood Pressure

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

U.S. FDA Resources

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

Locations

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

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Study Chair:

CDA Stehouwer, Prof.

Univeristy Hospital Maastricht

More Information

No publications provided

Responsible Party:	University Hospital Maastricht ( Prof. CDA Stehouwer )
Study ID Numbers:	MEC 07-2-115
Study First Received:	August 26, 2008
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00742066 History of Changes
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

Additional relevant MeSH terms:

Vasodilator Agents
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Irbesartan
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Pharmacologic Actions
Insulin

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Hyperinsulinism
Hypoglycemic Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Anti-Arrhythmia Agents
Insulin Resistance
Glucose Metabolism Disorders
Felodipine
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010