Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?
Recruitment status was Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?|
- Endothelial function
- Metabolic function
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259168
|Contact: Atheline Major-Pedersen, MDemail@example.com|
|Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital||Recruiting|
|Bispebjerg Bakke, Copenhagen, Copenhagen NV, Denmark, 2400|
|Contact: Atheline Major-Pedersen, MD 35316160 firstname.lastname@example.org|
|Contact: Christian Torp-Pedersen, MD, DMSc 35316159 email@example.com|
|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|