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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 : Completed
First Posted : November 29, 2005
Last Update Posted : December 3, 2018
Sponsor:
Collaborators:
Novartis
Bayer
Information provided by (Responsible Party):
Atheline Major-Pedersen, Bispebjerg Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Nateglinide




Primary Outcome Measures :
  1. Endothelial function

Secondary Outcome Measures :
  1. Metabolic function


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Insulin resistance, impaired glucose tolerance

Exclusion Criteria:

  • unstable chronic disease, acute disease

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


Locations
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Denmark
Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital
Bispebjerg Bakke, Copenhagen, Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Atheline Major-Pedersen
Novartis
Bayer
Investigators
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Study Chair: Christian Torp-Pedersen, MD, DMSc Bispebjerg Hospital
Publications:
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Responsible Party: Atheline Major-Pedersen, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00259168    
Other Study ID Numbers: 02-005/03
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Keywords provided by Atheline Major-Pedersen, Bispebjerg Hospital:
Postprandial endothelial function
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Nateglinide
Hypoglycemic Agents
Physiological Effects of Drugs