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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
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00742066
First received: August 26, 2008
Last updated: March 16, 2011
Last verified: March 2011
History of Changes
  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:

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:

  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
  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 May 21, 2013