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

• ClinicalTrials.gov Identifier: NCT00259168
• Recruitment Status: Completed
• First Posted: November 29, 2005
• Last Update Posted: December 3, 2018
• Sponsor: Atheline Major-Pedersen
• Collaborators: Novartis; Bayer
• Information provided by (Responsible Party): Atheline Major-Pedersen, Bispebjerg Hospital

Tracking Information

• First Submitted Date: November 28, 2005
• First Posted Date: November 29, 2005
• Last Update Posted Date: December 3, 2018
• Study Start Date: June 2003
• Actual Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 28, 2005): Endothelial function
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 28, 2005): Metabolic function
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?
• Official Title: Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?
• 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.

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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Insulin Resistance
• Impaired Fasting Glucose

• Intervention: Drug: Nateglinide
• Study Arms: Not Provided

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 28, 2005): 70
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2006
• Actual Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Insulin resistance, impaired glucose tolerance

Exclusion Criteria:

• unstable chronic disease, acute disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00259168
• Other Study ID Numbers: 02-005/03
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Atheline Major-Pedersen, Bispebjerg Hospital
• Study Sponsor: Atheline Major-Pedersen

Collaborators

• Novartis
• Bayer

Investigators

• Study Chair: Christian Torp-Pedersen, MD, DMSc; Bispebjerg Hospital

• PRS Account: Bispebjerg Hospital
• Verification Date: November 2018