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

NCT00742066 | Unknown

• 1 other identifier: MEC 07-2-115
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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?

Conditions

Hypertension; Insulin Resistance; Microcirculation

Keywords

Hypertension; Insulin resistance; Microcirculation; Angiotensin II receptor blocker

Outcome Measures

Primary Outcomes (1)

• functional recruitment of capillaries in the skin

  July 2009

Secondary Outcomes (4)

• perfused capillary density in the nailfold

  July 2009

• Endothelium- (in)dependent vasodilatation of finger skin microcirculation

  July 2009

• Density of arterioles, capillaries and venules in the bulbar conjunctiva.

  July 2009

• Diameter of arterioles and venules in the bulbar conjunctiva

  July 2009

Study Arms (3)

I

EXPERIMENTAL

Irbesartan

Drug: Irbesartan

II

ACTIVE COMPARATOR

Felodipine

Drug: Felodipine

III

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Irbesartan DRUG

Single dose 600mg orally

Also known as: Aprovel C09CA04

I

Felodipine DRUG

single dose 10mg Felodipine ER

Also known as: Plendil C08CA02

II

Placebo DRUG

Single dose tablet orally

III

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• hypertensive subjects:
• years
• Caucasian
• untreated hypertension \>140/90mmHg.
• normotensive subjects:
• years
• Caucasian
• Blood pressure \<140/90 mmHg.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

University Hospital Maastricht

Maastricht, P.O. Box 5800, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Hypertension; Insulin Resistance

Interventions

Irbesartan; Felodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Dihydropyridines; Pyridines

Study Officials

• CDA Stehouwer, Prof.

  Univeristy Hospital Maastricht

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 17, 2011

Record last verified: 2011-03

Locations

NL (1)