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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)

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ClinicalTrials.gov Identifier: NCT01829945
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Patrick Couture, Laval University

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.


Condition or disease
Metabolic Syndrome X

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study of the Relationships Between Apolipoprotein B-48 Kinetics and Expression of Genes That Regulate Intestinal Lipid Metabolism in Men With the Metabolic Syndrome.
Study Start Date : October 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2011





Primary Outcome Measures :
  1. Change in TRL apolipoproteinB-48 production rate. [ Time Frame: Week 1 ]

Secondary Outcome Measures :
  1. Changes in duodenal expression of genes that regulate intestinal lipid absorption. [ Time Frame: Week 1 ]
    Genes that regulate intestinal lipid absorption that will be measured are Niemann-Pick C1-like-1 (NPC1L1), Adenosine triphosphate(ATP)-binding cassette transporters (ABCG5/8), Fatty Acid Binding Protein (FABP), Sterol Regulatory Element Binding Protein (SREBP)

  2. Change in duodenal expression of genes that regulate intestinal lipid synthesis. [ Time Frame: Week 1 ]
    Genes that regulate intestinal lipid synthesis that will be measured are Acyl-Coenzyme A (CoA): diacylglycerol acyltransferase (DGAT), Acyl-CoA:cholesterol O-transferase 2 (ACAT2) and 3-hydroxy-methylglutaryl-CoA reductase (HMG CoA reductase).

  3. Change in synthesis of apolipoproteinB-48 containing lipoproteins (Microsomal triglyceride transfer protein (MTP), apolipoproteinB-48). [ Time Frame: Week 1 ]

Biospecimen Retention:   Samples With DNA
Serum Plasma Intestinal tissue


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
community sample
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829945


Locations
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Canada
Institute of Nutrition and Functional Foods (INAF)
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Patrick Couture, MD, FRCP, PhD Laval University

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Responsible Party: Patrick Couture, MD, FRCP, PhD, Laval University
ClinicalTrials.gov Identifier: NCT01829945     History of Changes
Other Study ID Numbers: INAF-129-05-02
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases