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

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ClinicalTrials.gov Identifier: NCT00259168
Recruitment Status : Unknown
Verified November 2005 by Bispebjerg Hospital.
Recruitment status was:  Recruiting
First Posted : November 29, 2005
Last Update Posted : November 29, 2005
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Impaired Fasting Glucose Drug: Nateglinide Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?
Study Start Date : June 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Nateglinide
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Endothelial function

Secondary Outcome Measures :
  1. Metabolic function

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Insulin resistance, impaired glucose tolerance

Exclusion Criteria:

  • unstable chronic disease, acute disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259168


Contacts
Contact: Atheline Major-Pedersen, MD 35316160 atmp@heart.dk

Locations
Denmark
Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital Recruiting
Bispebjerg Bakke, Copenhagen, Copenhagen NV, Denmark, 2400
Contact: Atheline Major-Pedersen, MD    35316160    atmp@heart.dk   
Contact: Christian Torp-Pedersen, MD, DMSc    35316159    ctp@heart.dk   
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
Novartis
Bayer
Investigators
Study Chair: Christian Torp-Pedersen, MD, DMSc Bispebjerg Hospital
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00259168     History of Changes
Other Study ID Numbers: 02-005/03
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: November 29, 2005
Last Verified: November 2005

Keywords provided by Bispebjerg Hospital:
Postprandial endothelial function

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Nateglinide
Hypoglycemic Agents
Physiological Effects of Drugs