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Role of Angiotensin II in Insulin-induced Microvascular Activity

Primary Purpose

Insulin Sensitivity, Microcirculation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Angiotensin II
Phenylephrine
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 Insulin Sensitivity focused on measuring Angiotensin II

Eligibility Criteria

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

Inclusion Criteria:

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

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Active Comparator

Arm Label

Placebo

Angiotensin II

Phenylephrine

Arm Description

Placebo

Angiotensin II

Phenylephrine

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
Insulin sensitivity

Full Information

First Posted
November 30, 2009
Last Updated
December 1, 2009
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01024543
Brief Title
Role of Angiotensin II in Insulin-induced Microvascular Activity
Official Title
Role of Angiotensin II in Insulin-induced Microvascular Activity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (undefined)

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 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Microcirculation
Keywords
Angiotensin II

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Placebo
Arm Title
Angiotensin II
Arm Type
Experimental
Arm Description
Angiotensin II
Arm Title
Phenylephrine
Arm Type
Active Comparator
Arm Description
Phenylephrine
Intervention Type
Drug
Intervention Name(s)
Angiotensin II
Intervention Description
Angiotensin II
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
Phenylephrine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
functional recruitment of capillaries in the skin
Time Frame
January 2009
Secondary Outcome Measure Information:
Title
perfused capillary density in the nailfold
Time Frame
January 2009
Title
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Time Frame
January 2006
Title
Insulin sensitivity
Time Frame
January 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CDA Stehouwer, Prof
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht, P.o. Box 5800, Netherlands
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

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Role of Angiotensin II in Insulin-induced Microvascular Activity

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