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

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ClinicalTrials.gov 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
Sponsor:
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

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
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




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 ]


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

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

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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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prof. CDA Stehouwer, University Hospital Maastricht
ClinicalTrials.gov Identifier: NCT00742066     History of Changes
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:
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
Insulin
Irbesartan
Felodipine
Angiotensin II
Angiotensinogen
Hypoglycemic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents