NCT00742456

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

1.6 years

First QC Date

August 26, 2008

Last Update Submit

February 22, 2011

Conditions

HypertensionObesity

Keywords

MicrocirculationInsulinHypertensionObesity

Outcome Measures

Primary Outcomes (1)

  • Functional recruitment of capillaries in the skin.

    January 2009 - January 2010

Secondary Outcomes (5)

  • Perfused capillary density in the nailfold.

    January 2009 - January 2010

  • Endothelium- (in)dependent vasodilatation of finger skin microcirculation

    January 2009 - January 2010

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

    January 2009 - January 2010

  • Diameter of arterioles and venules in the bulbar conjunctiva.

    January 2009 - January 2010

  • Insulin sensitivity (HOMA-IR)

    January 2009 - January 2010

Study Arms (2)

I

EXPERIMENTAL

Glucose

Dietary Supplement: Glucose solution

II

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Glucose solutionDIETARY_SUPPLEMENT

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

I
PlaceboDIETARY_SUPPLEMENT

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

II

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy normotensive subjects:
  • years
  • Caucasian
  • Blood pressure \<140/90 mmHg
  • obese normotensive subjects:
  • years
  • Caucasian
  • Blood pressure \<140/90 mmHg
  • BMI 30-38kg/m2
  • hypertensive subjects:
  • years
  • Caucasian
  • Untreated hypertension \>140/90mmHg.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

HypertensionObesityInsulin Resistance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • CDA Stehouwer, Prof.

    Univeristy Hospital Maastricht

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 27, 2008

Study Start

January 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

NL(1)