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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Maastricht University Medical Center.
Recruitment status was  Active, not recruiting
Information provided by:
Maastricht University Medical Center Identifier:
First received: August 26, 2008
Last updated: March 16, 2011
Last verified: March 2011
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
Insulin Resistance
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:

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
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


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00742066

University Hospital Maastricht
Maastricht, P.O. Box 5800, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Study Chair: CDA Stehouwer, Prof. Univeristy Hospital Maastricht
  More Information

Responsible Party: Prof. CDA Stehouwer, University Hospital Maastricht 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:
Insulin resistance
Angiotensin II receptor blocker

Additional relevant MeSH terms:
Insulin Resistance
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Angiotensin II
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vasodilator Agents processed this record on May 26, 2016