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Microvascular Dilatation After Endogenous Induced Hyperinsulinemia

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00742456
First received: August 26, 2008
Last updated: February 22, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
Obesity
 Dietary Supplement: Glucose solution
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Insulin-induced Microvascular Dilatation During a Physiological Stimulus - Studies in Hypertension and Obesity.

Resource links provided by NLM:

Drug Information available for: Dextrose
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 - January 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perfused capillary density in the nailfold. [ Time Frame: January 2009 - January 2010 ] [ Designated as safety issue: No ]
  • Endothelium- (in)dependent vasodilatation of finger skin microcirculation [ Time Frame: January 2009 - January 2010 ] [ Designated as safety issue: No ]
  • Density of arterioles, capillaries and venules in the bulbar conjunctiva. [ Time Frame: January 2009 - January 2010 ] [ Designated as safety issue: No ]
  • Diameter of arterioles and venules in the bulbar conjunctiva. [ Time Frame: January 2009 - January 2010 ] [ Designated as safety issue: No ]
  • Insulin sensitivity (HOMA-IR) [ Time Frame: January 2009 - January 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Glucose
 Dietary Supplement: Glucose solution
single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water)
Placebo Comparator: II
Placebo
 Dietary Supplement: Placebo
single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742456

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Chair: CDA Stehouwer, Prof. Univeristy Hospital Maastricht
  More Information

No publications provided

Responsible Party: Prof. CDA Stehouwer, University Hospital Maastricht
ClinicalTrials.gov Identifier: NCT00742456     History of Changes
Other Study ID Numbers: 08-2-031 MEC
Study First Received: August 26, 2008
Last Updated: February 22, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Microcirculation
Insulin
Hypertension
Obesity

Additional relevant MeSH terms:
Dilatation, Pathologic
Hyperinsulinism
Hypertension
Obesity
Pathological Conditions, Anatomical
Glucose Metabolism Disorders
Metabolic Diseases
 Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013