Microvascular Dilatation After Endogenous Induced Hyperinsulinemia

Not Applicable

Completed

• Conditions: Hypertension; Obesity
• Interventions: Dietary Supplement: Glucose solution; Dietary Supplement: Placebo

• Registration Number: NCT00742456
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Study Start: 2009-01
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
I	Glucose solution	Glucose
II	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Functional recruitment of capillaries in the skin.	January 2009 - January 2010

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands