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:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
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:

MedlinePlus related topics: Diabetes Medicines High Blood Pressure

Drug Information available for: Insulin Insulin beef 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
Experimental: I Irbesartan	Drug: Irbesartan Single dose 600mg orally Other Name: Aprovel C09CA04
Active Comparator: II Felodipine	Drug: Felodipine single dose 10mg Felodipine ER Other Name: Plendil C08CA02
Placebo Comparator: III 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
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:	Prof. CDA Stehouwer, University Hospital Maastricht
ClinicalTrials.gov Identifier:	NCT00742066 History of Changes
Other Study ID Numbers:	MEC 07-2-115
Study First Received:	August 26, 2008
Last Updated:	March 16, 2011
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:

Hypertension
Insulin Resistance
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Angiotensin II
Felodipine
Irbesartan
Insulin
Angiotensin Receptor Antagonists
Vasoconstrictor Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on February 09, 2012