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

August 26, 2008
February 22, 2011
January 2009
August 2010   (final data collection date for primary outcome measure)
Functional recruitment of capillaries in the skin. [ Time Frame: January 2009 - January 2010 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00742456 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Microvascular Dilatation After Endogenous Induced Hyperinsulinemia
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Hypertension
  • Obesity
  • Dietary Supplement: Glucose solution
    single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water)
  • Dietary Supplement: Placebo
    single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally
  • Experimental: I
    Glucose
    Intervention: Dietary Supplement: Glucose solution
  • Placebo Comparator: II
    Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00742456
08-2-031 MEC
No
Prof. CDA Stehouwer, University Hospital Maastricht
Maastricht University Medical Center
Not Provided
Study Chair: CDA Stehouwer, Prof. Univeristy Hospital Maastricht
Maastricht University Medical Center
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP