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

Hypertension Clinical Trial

Official title:

Insulin-induced Microvascular Activity in Patients With Essential Hypertension: a Possible Role for Angiotensin II AT1-receptor Blockers.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00742066
• Other study ID #: MEC 07-2-115
• Status: Active, not recruiting
• Phase: N/A
• First received: August 26, 2008
• Last updated: March 16, 2011
• Start date: March 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertension
• Insulin Resistance
• Microcirculation

Intervention

Drug:
• Irbesartan
Single dose 600mg orally
• Felodipine
single dose 10mg Felodipine ER
• Placebo
Single dose tablet orally

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht	P.O. Box 5800

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional recruitment of capillaries in the skin		July 2009	No
Secondary	perfused capillary density in the nailfold		July 2009	No
Secondary	Endothelium- (in)dependent vasodilatation of finger skin microcirculation		July 2009	No
Secondary	Density of arterioles, capillaries and venules in the bulbar conjunctiva.		July 2009	No
Secondary	Diameter of arterioles and venules in the bulbar conjunctiva		July 2009	No