Skip to main content
OpenTrials
Completed

NCT Number: NCT00259168

Insulin Resistance and Vessel Function After Meals: 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Impaired Fasting Glucose Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital

Bispebjerg Bakke, Copenhagen, Copenhagen NV, 2400, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Insulin resistance, impaired glucose tolerance

Exclusion criteria

  • unstable chronic disease, acute disease

Treatment and study plan

nateglinide

Drug

Primary outcomes

  1. Endothelial function

Secondary outcomes

  1. Metabolic function

Sponsors and collaborators

Lead sponsor

Atheline Major-Pedersen

Other

Collaborators

  • Bayer
  • Novartis

Registry information

Official study title

Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Nov 29, 2005
Registry last updated
Dec 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.