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NCT Number: NCT01829945

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)

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.

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Institute of Nutrition and Functional Foods (INAF)

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in TRL apolipoproteinB-48 production rate.

    Time frame: Week 1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 11, 2013
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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