Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?
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|ClinicalTrials.gov Identifier: NCT00259168|
Recruitment Status : Unknown
Verified November 2005 by Bispebjerg Hospital.
Recruitment status was: Recruiting
First Posted : November 29, 2005
Last Update Posted : November 29, 2005
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance Impaired Fasting Glucose||Drug: Nateglinide||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?|
|Study Start Date :||June 2003|
- Endothelial function
- Metabolic function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259168
|Contact: Atheline Major-Pedersen, MDfirstname.lastname@example.org|
|Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital||Recruiting|
|Bispebjerg Bakke, Copenhagen, Copenhagen NV, Denmark, 2400|
|Contact: Atheline Major-Pedersen, MD 35316160 email@example.com|
|Contact: Christian Torp-Pedersen, MD, DMSc 35316159 firstname.lastname@example.org|
|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|
|Study Chair:||Christian Torp-Pedersen, MD, DMSc||Bispebjerg Hospital|