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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742066
Recruitment Status : Unknown
Verified March 2011 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2008
Last Update Posted : March 17, 2011
Information provided by:
Maastricht University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Insulin Resistance Microcirculation Drug: Irbesartan Drug: Felodipine Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
Study Start Date : March 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: I
Drug: Irbesartan
Single dose 600mg orally
Other Name: Aprovel C09CA04

Active Comparator: II
Drug: Felodipine
single dose 10mg Felodipine ER
Other Name: Plendil C08CA02

Placebo Comparator: III
Drug: Placebo
Single dose tablet orally

Primary Outcome Measures :
  1. functional recruitment of capillaries in the skin [ Time Frame: July 2009 ]

Secondary Outcome Measures :
  1. perfused capillary density in the nailfold [ Time Frame: July 2009 ]
  2. Endothelium- (in)dependent vasodilatation of finger skin microcirculation [ Time Frame: July 2009 ]
  3. Density of arterioles, capillaries and venules in the bulbar conjunctiva. [ Time Frame: July 2009 ]
  4. Diameter of arterioles and venules in the bulbar conjunctiva [ Time Frame: July 2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742066

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University Hospital Maastricht
Maastricht, P.O. Box 5800, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
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Study Chair: CDA Stehouwer, Prof. Univeristy Hospital Maastricht
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Responsible Party: Prof. CDA Stehouwer, University Hospital Maastricht Identifier: NCT00742066    
Other Study ID Numbers: MEC 07-2-115
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: March 2011
Keywords provided by Maastricht University Medical Center:
Insulin resistance
Angiotensin II receptor blocker
Additional relevant MeSH terms:
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Insulin Resistance
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents