Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259168
Status:
COMPLETED
Last Update Posted:
2018-12-03
First Post:
2005-11-28
Brief Title:
Insulin Resistance and Vessel Function After Meals Does Early Intervention Make a Difference
Sponsor:
Atheline Major-Pedersen
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
Insulin Resistance and Postprandial Endothelial Function Does Early Intervention Make a Difference
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether attenuationnormalization of elevated blood sugar after meals ameliorates vessel wall endothelial function in individuals with insulin resistance
Detailed Description:
BackgroundInsulin 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 interventionobservation period
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 interventionobservation period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None