Microvascular Dilatation After Endogenous Induced Hyperinsulinemia

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742456
• Other study ID #: 08-2-031 MEC
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: February 22, 2011
• Start date: January 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertension
• Obesity

Intervention

Dietary Supplement:
• Glucose solution
single oral intake of 250 ml glucose solution (75gr sugar in 250ml of water)
• Placebo
single intake of placebo solution (250ml of sweet flavored water, no sugar added), orally

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional recruitment of capillaries in the skin.		January 2009 - January 2010	No
Secondary	Perfused capillary density in the nailfold.		January 2009 - January 2010	No
Secondary	Endothelium- (in)dependent vasodilatation of finger skin microcirculation		January 2009 - January 2010	No
Secondary	Density of arterioles, capillaries and venules in the bulbar conjunctiva.		January 2009 - January 2010	No
Secondary	Diameter of arterioles and venules in the bulbar conjunctiva.		January 2009 - January 2010	No
Secondary	Insulin sensitivity (HOMA-IR)		January 2009 - January 2010	No