Role of Angiotensin II in Insulin-induced Microvascular A... | NCT01024543

Studies
Role of Angiotensin II in Insulin-induced Microvascular Activity

NCT01024543

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Dec 2, 2009Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Insulin Sensitivity
Microcirculation

Interventions

Angiotensin II
Phenylephrine
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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009

First Submitted Date

Nov 30, 2009

First Submission Date that Met QC Criteria

Dec 1, 2009

First Posted Date

Dec 2, 2009Estimated

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

Dec 1, 2009

Last Update Posted Date

Dec 2, 2009Estimated

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 infusion of Angiotensin II improves the insulin-induced microvascular dilatation and therefore insulin-mediated glucose uptake. Objectives: Does infusion of Angiotensin II increase insulin-mediated glucose uptake via enhanced insulin-mediated microvascular function in healthy 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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Sham Comparator	Placebo	Drug: Placebo
Angiotensin II	Experimental	Angiotensin II	Drug: Angiotensin II
Phenylephrine	Active Comparator	Phenylephrine	Drug: Phenylephrine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Angiotensin II	Drug	Angiotensin II	Angiotensin II
Phenylephrine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
perfused capillary density in the nailfold		January 2009
Endothelium- (in)dependent vasodilatation of finger skin microcirculation		January 2006
Insulin sensitivity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.18-60 years 2.Caucasian 3.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	Maastricht University Medical Centre	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Centre		Maastricht, P.o. Box 5800, Netherlands		6202 AZ	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000804	Angiotensin II
D010656	Phenylephrine

Ancestor Terms

ID	Term
D000809	Angiotensins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided