Study of the Relationships Between Apolipoprotein B-48 Kinetics and Expression of Genes That Regulate Intestinal Lipid Metabolism in Men With the Metabolic Syndrome (SMB48)

NCT ID: NCT01829945

Last Updated: 2013-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-02-28

Brief Summary

Several lines of evidence indicate that a significant proportion of cardiovascular disease (CVD) events are attributable to the presence of a cluster of metabolic abnormalities and perturbations, defined as the metabolic syndrome. It has been estimated that approximately 25% of the North American adult population is living with the metabolic syndrome. Recent studies show that overaccumulation of atherogenic triglyceride-rich lipoproteins (TRL) seen in insulin-resistant patients is partly due to increased production rate of intestinally derived apolipoproteinB-48-containing lipoproteins. This is of interest because substantial evidence exists indicating that elevated levels of intestinal lipoproteins are associated with increased CVD risk. However, as indicated in the body of this grant proposal, the underlying mechanisms that lead to intestinal overproduction of lipoproteins in insulin-resistant states are poorly understood.

The general objective of the proposed research is to investigate the mechanisms by which the metabolic syndrome affects apolipoproteinB-48 secretion in human. The primary hypothesis is that insulin resistance will be associated with higher levels of intestinal lipoproteins because of an increased secretion of these particles.

Conditions

Metabolic Syndrome X

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

Subjects with metabolic syndrome:

• Men aged between 18-60 years
• Waist circumference >102
• HDL-cholesterol < 1.1 mmol/L
• Triglycerides > 1.7 mmol/L
• Fasting blood glucose >6.1 mmol/L
• Normal blood pressure (<130/85)

Controls:

• Men aged between 18-60 years
• Waist circumference >102
• HDL-cholesterol > 1.1 mmol/L
• Triglycerides < 1.7 mmol/L
• Fasting blood glucose <6.1 mmol/L
• Normal blood pressure (<130/85)

Exclusion Criteria

• Women
• Men < 18 or > 60 years
• Smokers (> 1 cigarette/day)
• Body weight variation > 10% during the last 6 months prior to the study baseline
• Subjects with a previous history of cardiovascular disease
• Subjects with Type 2 diabetes
• Subjects with a monogenic dyslipidemia
• Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa
• Subjects with endocrine or gastrointestinal disorders
• History of alcohol or drug abuse within the past 2 years
• Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Patrick Couture

MD, FRCP, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Couture, MD, FRCP, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Institute of Nutrition and Functional Foods (INAF)

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

INAF-129-05-02

Identifier Type: -

Identifier Source: org_study_id