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

Phase 4

Completed

• Conditions: Impaired Fasting Glucose; Insulin Resistance

• Registration Number: NCT00259168
• Lead Sponsor: Atheline Major-Pedersen

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-11-29
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Insulin resistance, impaired glucose tolerance

Exclusion Criteria

• unstable chronic disease, acute disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endothelial function

Secondary Outcome Measures

Name	Time	Method
Metabolic function

Trial Locations

Locations (1)

Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital; 🇩🇰 Bispebjerg Bakke, Copenhagen, Copenhagen NV, Denmark

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

🇩🇰Bispebjerg Bakke, Copenhagen, Copenhagen NV, Denmark