Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference? - Full Text View

Sponsors and Collaborators:	Bispebjerg Hospital Novartis Bayer
Information provided by:	Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT00259168

Purpose

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 IV

Drug Information available for: Insulin A 4166

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?

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.

Eligibility

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

Criteria

Inclusion Criteria:

Insulin resistance, impaired glucose tolerance

Exclusion Criteria:

unstable chronic disease, acute disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259168

Contacts

Contact: Atheline Major-Pedersen, MD

35316160

atmp@heart.dk

Locations

Denmark, Copenhagen NV
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:

Ceriello A, Taboga C, Tonutti L, Quagliaro L, Piconi L, Bais B, Da Ros R, Motz E. Evidence for an independent and cumulative effect of postprandial hypertriglyceridemia and hyperglycemia on endothelial dysfunction and oxidative stress generation: effects of short- and long-term simvastatin treatment. Circulation. 2002 Sep 3;106(10):1211-8.

Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5.

Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. Erratum in: J Am Coll Cardiol 2002 Mar 20;39(6):1082.

Study ID Numbers:	02-005/03
Study First Received:	November 28, 2005
Last Updated:	November 28, 2005
ClinicalTrials.gov Identifier:	NCT00259168
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

Study placed in the following topic categories:

Hyperinsulinism
Metabolic Diseases
Nateglinide
Insulin Resistance

Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009