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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00259168
Enrollment
70
Registered
2005-11-29
Start date
2003-06-30
Completion date
2006-03-31
Last updated
2018-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Fasting Glucose, Insulin Resistance

Keywords

Postprandial endothelial function

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.

Interventions

Sponsors

Novartis
CollaboratorINDUSTRY
Bayer
CollaboratorINDUSTRY
Atheline Major-Pedersen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years

Inclusion criteria

* Insulin resistance, impaired glucose tolerance

Exclusion criteria

* unstable chronic disease, acute disease

Design outcomes

Primary

MeasureTime frame
Endothelial function

Secondary

MeasureTime frame
Metabolic function

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026