Microvascular Dilatation After Endogenous Induced Hyperinsulinemia

February 22, 2011 updated by: Maastricht University Medical Center

Insulin-induced Microvascular Dilatation During a Physiological Stimulus - Studies in Hypertension and Obesity.

In this study we will examine if the insulin-induced microvascular effects will occur after a physiological stimulus (i.e. a oral glucose tolerance test). With that the physiological importance of the insulin-induced microvascular dilatation can be elucidated. In this study we hypothesize that oral glucose intake and consequently the endogenous induced hyperinsulinemia will lead to insulin-induced microvascular dilatation in healthy normotensive subjects. Furthermore, we suggest that the insulin-mediated microvascular dilatation, resulting from this physiological induced hyperinsulinemia, will be less in hypertensive and obese subjects compared to healthy controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • University Hospital Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

healthy normotensive subjects:

  1. 18-60 years
  2. Caucasian
  3. Blood pressure <140/90 mmHg

obese normotensive subjects:

  1. 18-60 years
  2. Caucasian
  3. Blood pressure <140/90 mmHg
  4. BMI 30-38kg/m2

hypertensive subjects:

  1. 18-60 years
  2. Caucasian
  3. Untreated hypertension >140/90mmHg.

Exclusion Criteria for healthy normotensive and hypertensive subjects:

  1. Obesity (BMI>27kg/m2)
  2. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
  3. 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

for normotensive obese subjects:

  1. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
  2. Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA
  3. Smoking
  4. Alcohol use >4U/day
  5. Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs)
  6. Pregnancy
  7. Wearing contact lenses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: II
Placebo
Dietary supplement: Placebo
single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally
Experimental: I
Glucose
Dietary supplement: Glucose solution
single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional recruitment of capillaries in the skin.
Time Frame: January 2009 - January 2010
January 2009 - January 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Perfused capillary density in the nailfold.
Time Frame: January 2009 - January 2010
January 2009 - January 2010
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
Time Frame: January 2009 - January 2010
January 2009 - January 2010
Density of arterioles, capillaries and venules in the bulbar conjunctiva.
Time Frame: January 2009 - January 2010
January 2009 - January 2010
Diameter of arterioles and venules in the bulbar conjunctiva.
Time Frame: January 2009 - January 2010
January 2009 - January 2010
Insulin sensitivity (HOMA-IR)
Time Frame: January 2009 - January 2010
January 2009 - January 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Study Chair: CDA Stehouwer, Prof., Univeristy Hospital Maastricht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimate)

August 27, 2008

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-2-031 MEC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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