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

Primary Purpose

Hypertension, Insulin Resistance, Microcirculation

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Irbesartan
Felodipine
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension focused on measuring Hypertension, Insulin resistance, Microcirculation, Angiotensin II receptor blocker

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Maastricht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

I

II

III

Arm Description

Irbesartan

Felodipine

Placebo

Outcomes

Primary Outcome Measures

functional recruitment of capillaries in the skin

Secondary Outcome Measures

perfused capillary density in the nailfold
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Density of arterioles, capillaries and venules in the bulbar conjunctiva.
Diameter of arterioles and venules in the bulbar conjunctiva

Full Information

First Posted
August 26, 2008
Last Updated
March 16, 2011
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00742066
Brief Title
Role of AT1-receptor Blockers in Insulin-induced Vasodilation.
Official Title
Insulin-induced Microvascular Activity in Patients With Essential Hypertension: a Possible Role for Angiotensin II AT1-receptor Blockers.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Insulin Resistance, Microcirculation
Keywords
Hypertension, Insulin resistance, Microcirculation, Angiotensin II receptor blocker

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Irbesartan
Arm Title
II
Arm Type
Active Comparator
Arm Description
Felodipine
Arm Title
III
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Other Intervention Name(s)
Aprovel C09CA04
Intervention Description
Single dose 600mg orally
Intervention Type
Drug
Intervention Name(s)
Felodipine
Other Intervention Name(s)
Plendil C08CA02
Intervention Description
single dose 10mg Felodipine ER
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose tablet orally
Primary Outcome Measure Information:
Title
functional recruitment of capillaries in the skin
Time Frame
July 2009
Secondary Outcome Measure Information:
Title
perfused capillary density in the nailfold
Time Frame
July 2009
Title
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Time Frame
July 2009
Title
Density of arterioles, capillaries and venules in the bulbar conjunctiva.
Time Frame
July 2009
Title
Diameter of arterioles and venules in the bulbar conjunctiva
Time Frame
July 2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: hypertensive subjects: 18-60 years Caucasian untreated hypertension >140/90mmHg. normotensive subjects: 18-60 years Caucasian Blood pressure <140/90 mmHg. Exclusion Criteria: Obesity (BMI>27kg/m2) Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure) Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA Smoking Alcohol use >4U/day Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs) Pregnancy Wearing contact lenses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CDA Stehouwer, Prof.
Organizational Affiliation
Univeristy Hospital Maastricht
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
State/Province
P.O. Box 5800
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

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

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