Insulin Resistance Clinical Trial
Official title:
Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?
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.
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.
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