NCT01024543

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

Enrollment Period

3.1 years

First QC Date

November 30, 2009

Last Update Submit

December 1, 2009

Conditions

Insulin SensitivityMicrocirculation

Keywords

Angiotensin II

Outcome Measures

Primary Outcomes (1)

  • functional recruitment of capillaries in the skin

    January 2009

Secondary Outcomes (3)

  • perfused capillary density in the nailfold

    January 2009

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

    January 2006

  • Insulin sensitivity

    January 2009

Study Arms (3)

Placebo

SHAM COMPARATOR

Placebo

Drug: Placebo

Angiotensin II

EXPERIMENTAL

Angiotensin II

Drug: Angiotensin II

Phenylephrine

ACTIVE COMPARATOR

Phenylephrine

Drug: Phenylephrine

Interventions

Angiotensin IIDRUG

Angiotensin II

Angiotensin II
PhenylephrineDRUG

Phenylephrine

Phenylephrine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years 2.Caucasian 3.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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

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

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Angiotensin IIPhenylephrine

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AngiotensinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsAutacoidsInflammation MediatorsBiological FactorsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • CDA Stehouwer, Prof

    Maastricht University Medical Centre

    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

November 30, 2009

First Posted

December 2, 2009

Study Start

October 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations

NL(1)