Microvascular Dilatation After Endogenous Induced Hyperinsulinemia

NCT ID: NCT00742456

Last Updated: 2011-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-08-31

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.

Conditions

Hypertension; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

I

Glucose

Group Type: EXPERIMENTAL

Glucose solution

Intervention Type: DIETARY_SUPPLEMENT

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

II

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Glucose solution

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Maastricht

Principal Investigators

CDA Stehouwer, Prof.

Role: STUDY_CHAIR

Univeristy Hospital Maastricht

Locations

University Hospital Maastricht

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

08-2-031 MEC

Identifier Type: -

Identifier Source: org_study_id