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Completed

NCT Number: NCT00742456

Microvascular Dilatation After Endogenous Induced Hyperinsulinemia

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.

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Key information

Conditions

Hypertension Body Weight Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy normotensive subjects:

  • 18-60 years
  • Caucasian
  • Blood pressure <140/90 mmHg

obese normotensive subjects:

  • 18-60 years
  • Caucasian
  • Blood pressure <140/90 mmHg
  • BMI 30-38kg/m2

hypertensive subjects:

  • 18-60 years
  • Caucasian
  • Untreated hypertension >140/90mmHg.

Exclusion criteria

for healthy normotensive and hypertensive subjects:

  • Obesity (BMI>27kg/m2)
  • Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure)
  • 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

for normotensive obese subjects:

  • 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

Treatment and study plan

Glucose solution

Dietary Supplement

single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water)

Placebo

Dietary Supplement

single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally

Primary outcomes

  1. Functional recruitment of capillaries in the skin.

    Time frame: January 2009 - January 2010

Secondary outcomes

  1. Perfused capillary density in the nailfold.

    Time frame: January 2009 - January 2010

  2. Endothelium- (in)dependent vasodilatation of finger skin microcirculation

    Time frame: January 2009 - January 2010

  3. Density of arterioles, capillaries and venules in the bulbar conjunctiva.

    Time frame: January 2009 - January 2010

  4. Diameter of arterioles and venules in the bulbar conjunctiva.

    Time frame: January 2009 - January 2010

  5. Insulin sensitivity (HOMA-IR)

    Time frame: January 2009 - January 2010

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2008
Registry last updated
Feb 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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