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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
Hypertension Insulin Resistance Microcirculation Drug: Irbesartan Drug: Felodipine Drug: Placebo

Study Type: Interventional
Study Design: 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.

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 ]

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

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   (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
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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

Keywords provided by Maastricht University Medical Center:
Insulin resistance
Angiotensin II receptor blocker

Additional relevant MeSH terms:
Insulin Resistance
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Angiotensin II
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 processed this record on September 21, 2017