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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Bispebjerg Hospital.
Recruitment status was  Recruiting
Information provided by:
Bispebjerg Hospital Identifier:
First received: November 28, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted

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.

Condition Intervention Phase
Insulin Resistance
Impaired Fasting Glucose
Drug: Nateglinide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?

Resource links provided by NLM:

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Endothelial function

Secondary Outcome Measures:
  • Metabolic function

Estimated Enrollment: 70
Study Start Date: June 2003
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.


Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Insulin resistance, impaired glucose tolerance

Exclusion Criteria:

  • unstable chronic disease, acute disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT00259168

Contact: Atheline Major-Pedersen, MD 35316160

Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital Recruiting
Bispebjerg Bakke, Copenhagen, Copenhagen NV, Denmark, 2400
Contact: Atheline Major-Pedersen, MD    35316160   
Contact: Christian Torp-Pedersen, MD, DMSc    35316159   
Principal Investigator: Atheline Major-Pedersen, MD         
Sub-Investigator: Nikolaj Ihlemann, MD, Phd         
Sub-Investigator: Thomas S Hermann, MD         
Sub-Investigator: Helena Dominguez, MD, Phd         
Sub-Investigator: Britt Kveiborg, MD         
Sub-Investigator: Buris Christiansen         
Sub-Investigator: Christian Rask-Madsen, MD, Phd         
Sub-Investigator: Ole L Svendsen, MD, DMSc         
Sub-Investigator: Lars Køber, MD, DMsc         
Sub-Investigator: Dorthe B Braunberg, Lab tech.         
Sub-Investigator: Christian Torp-Pedersen, MD, DMSc         
Sponsors and Collaborators
Bispebjerg Hospital
Study Chair: Christian Torp-Pedersen, MD, DMSc Bispebjerg Hospital
  More Information

Publications: Identifier: NCT00259168     History of Changes
Other Study ID Numbers: 02-005/03
Study First Received: November 28, 2005
Last Updated: November 28, 2005
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee for the Counties of Copenhagen and Frederiksberg
Denmark: Danish Data agency

Keywords provided by Bispebjerg Hospital:
Postprandial endothelial function

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases processed this record on October 13, 2015