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Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?

A

Atheline Major-Pedersen

Status and phase

Completed
Phase 4

Conditions

Impaired Fasting Glucose
Insulin Resistance

Treatments

Drug: Nateglinide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00259168
02-005/03

Details and patient eligibility

About

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.

Full description

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.

Enrollment

70 patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Insulin resistance, impaired glucose tolerance

Exclusion criteria

  • unstable chronic disease, acute disease

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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