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

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00742066
Collaborator
(none)
32
Enrollment
1
Location
3
Arms
16
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2008
Anticipated Primary Completion Date :
Jul 1, 2009
Anticipated Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: I

Irbesartan

Drug: Irbesartan
Single dose 600mg orally
Other Names:
  • Aprovel C09CA04

    		•
    Active Comparator: II

    Felodipine

    Drug: Felodipine
    single dose 10mg Felodipine ER
    Other Names:
  • Plendil C08CA02

    		•
    Placebo Comparator: III

    Placebo

    Drug: Placebo
    Single dose tablet orally

    Outcome Measures

    Primary Outcome Measures

    1. functional recruitment of capillaries in the skin [July 2009]

    Secondary Outcome Measures

    1. perfused capillary density in the nailfold [July 2009]

    2. Endothelium- (in)dependent vasodilatation of finger skin microcirculation [July 2009]

    3. Density of arterioles, capillaries and venules in the bulbar conjunctiva. [July 2009]

    4. Diameter of arterioles and venules in the bulbar conjunctiva [July 2009]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00742066
    Other Study ID Numbers:
    • MEC 07-2-115
    First Posted:
    Aug 27, 2008
    Last Update Posted:
    Mar 17, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    Hypertension
    Insulin resistance
    Microcirculation
    Angiotensin II receptor blocker
    Additional relevant MeSH terms:
    Hypertension
    Insulin Resistance
    Felodipine
    Irbesartan

    Study Results

    No Results Posted as of Mar 17, 2011