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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00259168
Other study ID # 02-005/03
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2003
Est. completion date March 2006

Study information

Verified date November 2018
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers
Gender All
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria:

- Insulin resistance, impaired glucose tolerance

Exclusion Criteria:

- unstable chronic disease, acute disease

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nateglinide


Locations

Country Name City State
Denmark Endothelial laboratory, Cardiology clinic Y-research, H:S Bispebjerg Hospital Bispebjerg Bakke, Copenhagen Copenhagen NV

Sponsors (3)

Lead Sponsor Collaborator
Atheline Major-Pedersen Bayer, Novartis

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Endothelial function
Secondary Metabolic function
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