Role of AT1-receptor Blockers in Insulin-induced Vasodila... | NCT00742066

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

NCT00742066

Sponsor

Maastricht University Medical Center

Status

Unknown status

Last Update Posted

Mar 17, 2011Estimated

Enrollment

32Estimated

Phase

Not Applicable

Conditions

Hypertension
Insulin Resistance
Microcirculation

Interventions

Irbesartan
Felodipine
Placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jul 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Aug 26, 2008

First Submission Date that Met QC Criteria

Aug 26, 2008

First Posted Date

Aug 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2011

Last Update Posted Date

Mar 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Experimental	Irbesartan	Drug: Irbesartan
II	Active Comparator	Felodipine	Drug: Felodipine
III	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irbesartan	Drug	Single dose 600mg orally	I	Aprovel C09CA04

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
functional recruitment of capillaries in the skin		July 2009

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CDA Stehouwer, Prof.	Univeristy Hospital Maastricht	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Maastricht		Maastricht	P.O. Box 5800	6202 AZ	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077405	Irbesartan
D015736	Felodipine

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided