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Role of Angiotensin II in Insulin-induced Microvascular Activity

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01024543
First received: November 30, 2009
Last updated: December 1, 2009
Last verified: December 2009
History of Changes
  Purpose

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?


Condition Intervention
Insulin Sensitivity
Microcirculation
 Drug: Angiotensin II
Drug: Phenylephrine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Role of Angiotensin II in Insulin-induced Microvascular Activity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • functional recruitment of capillaries in the skin [ Time Frame: January 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • perfused capillary density in the nailfold [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Endothelium- (in)dependent vasodilatation of finger skin microcirculation [ Time Frame: January 2006 ] [ Designated as safety issue: No ]
  • Insulin sensitivity [ Time Frame: January 2009 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2006
Estimated Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Placebo
Placebo
 Drug: Placebo
Experimental: Angiotensin II
Angiotensin II
 Drug: Angiotensin II
Angiotensin II
Active Comparator: Phenylephrine
Phenylephrine
 Drug: Phenylephrine
Phenylephrine

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024543

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, P.o. Box 5800, Netherlands, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Chair: CDA Stehouwer, Prof Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Prof. CDA Stehouwer, Maastricht University Medical Centre
ClinicalTrials.gov Identifier: NCT01024543     History of Changes
Other Study ID Numbers: MEC 06-2-074
Study First Received: November 30, 2009
Last Updated: December 1, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Angiotensin II

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Angiotensin II
Phenylephrine
Oxymetazoline
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013