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

Insulin Resistance Clinical Trial

Official title:

Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259168
• Other study ID #: 02-005/03
• Status: Completed
• Phase: Phase 4
• 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
• 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
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Insulin resistance, impaired glucose tolerance

Exclusion Criteria:

• unstable chronic disease, acute disease

Related Conditions & MeSH terms

• Impaired Fasting Glucose
• Insulin Resistance

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