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Sponsors and Collaborators: |
Bispebjerg Hospital Novartis Bayer |
Information provided by: | Bispebjerg Hospital |
ClinicalTrials.gov Identifier: | NCT00259168 |
The purpose of this study is to determine whether attenuation/normalization of elevated blood sugar after meals ameliorates vessel wall (endothelial) function in individuals with insulin resistance.
Condition | Intervention | Phase |
Insulin Resistance Impaired Fasting Glucose |
Drug: Nateglinide |
Phase IV |
ChemIDplus related topics: | Insulin A 4166 |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference? |
Estimated Enrollment: | 70 |
Study Start Date: | June 2003 |
Background:Insulin Resistance (IR) is accompanied by a high incidence and prevalence of cardiovascular disease. IR is present in individuals with pre-diabetes/ type 2 diabetes. Epidemiological data demonstrate a tight relationship between postprandial blood sugar, insulin resistance and cardiovascular disease (CVD). Endothelial dysfunction seems to be the very first sign of CVD.
Purpose: We propose to determine whether attenuation /normalization of post-prandial hyperglycaemia, through the administration of an oral hypoglycaemic agent of ultra rapid action (nateglinide), ameliorates endothelial function in the IR.
We extrapolate that a better endothelial function in the brachial artery reflects regression of atherosclerotic changes in the coronary system.
Method and Study Design: Prospective, open, parallel, group comparison study of 1 intervention group, 1 intervention control group and 1 disease control group. The intervention group and the intervention control group each consist of 30 individuals with IR. Individuals in the intervention group receive an individually adjusted dose of nateglinide 3 times daily during 12 weeks. The third group consists of 10 healthy, young individuals. All groups are followed during 3 months with an otherwise unchanged lifestyle. Endothelial function is measured with the Flow Mediated Dilation method before and after the intervention/observation period.
Ages Eligible for Study: | 25 Years to 75 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Atheline Major-Pedersen, MD | 35316160 | atmp@heart.dk |
Denmark, Copenhagen NV | |||||
Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital | Recruiting | ||||
Bispebjerg Bakke, Copenhagen, Copenhagen NV, Denmark, 2400 | |||||
Contact: Atheline Major-Pedersen, MD 35316160 atmp@heart.dk | |||||
Contact: Christian Torp-Pedersen, MD, DMSc 35316159 ctp@heart.dk | |||||
Principal Investigator: Atheline Major-Pedersen, MD | |||||
Sub-Investigator: Nikolaj Ihlemann, MD, Phd | |||||
Sub-Investigator: Thomas S Hermann, MD | |||||
Sub-Investigator: Helena Dominguez, MD, Phd | |||||
Sub-Investigator: Britt Kveiborg, MD | |||||
Sub-Investigator: Buris Christiansen | |||||
Sub-Investigator: Christian Rask-Madsen, MD, Phd | |||||
Sub-Investigator: Ole L Svendsen, MD, DMSc | |||||
Sub-Investigator: Lars Køber, MD, DMsc | |||||
Sub-Investigator: Dorthe B Braunberg, Lab tech. | |||||
Sub-Investigator: Christian Torp-Pedersen, MD, DMSc |
Bispebjerg Hospital |
Novartis |
Bayer |
Study Chair: | Christian Torp-Pedersen, MD, DMSc | Bispebjerg Hospital |
Study ID Numbers: | 02-005/03 |
First Received: | November 28, 2005 |
Last Updated: | November 28, 2005 |
ClinicalTrials.gov Identifier: | NCT00259168 |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: Ethics Committee for the Counties of Copenhagen and Frederiksberg; Denmark: Danish Data agency |
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