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Effects of Macronutrients on Hepatic Lipids, Plasma Triglycerides, and Insulin Sensitivity (MACRONUTR)

This study has been completed.
Sponsor:
Information provided by:
University of Lausanne
ClinicalTrials.gov Identifier:
NCT00523562
First received: August 30, 2007
Last updated: October 27, 2010
Last verified: June 2010
History of Changes

August 30, 2007
October 27, 2010
July 2006
April 2008   (final data collection date for primary outcome measure)
  • plasma triglycerides [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • intra-hepatic lipids [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • insulin mediated glucose disposal [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • plasma triglycerides and free fatty acids [ Time Frame: 6 days ]
  • intra-hepatic lipids [ Time Frame: 6 days ]
  • insulin sensitivity [ Time Frame: 6 days ]
Complete list of historical versions of study NCT00523562 on ClinicalTrials.gov Archive Site
  • lipid oxidation [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • plasma beta-hydroxybutyrate [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • gene expression in skeletal muscle and adipose tissue [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • lipid oxidation [ Time Frame: 6 days ]
  • plasma beta-hydroxybutyrate [ Time Frame: 6 days ]
  • gene expression in skeletal muscle and adipose tissue [ Time Frame: 6 days ]
Not Provided
Not Provided
 
Effects of Macronutrients on Hepatic Lipids, Plasma Triglycerides, and Insulin Sensitivity
Study of the Role of Insulin Resistance in the Pathogenesis of the Metabolic Syndrome and of Non-alcoholic Steatohepatitis

The purpose of this study is to assess how the macronutrient composition of the diet effects

  • lipid and glucose metabolism
  • intrahepatic lipids
  • insulin sensitivity

in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and offsprings of patients with type 2 diabetes mellitus).

The study is aimed at assessing the effects of changes in total energy, sugars, lipids, and protein intake on intrahepatic lipids, plasma lipids, and hepatic and whole body insulin resistance in

  • lean men and women with no family history of diabetes
  • overweight men and women
  • lean men with a family history of type 2 diabetes

Subjects are studied after a 6-day period of

  • isocaloric diet with 100% calorie requirement, of which 55% carbohydrate, 15% protein, and 30% fat)
  • the same isocaloric diet supplemented with 3g/kg body weight/day fructose
  • hypercaloric high fat diet with 130% energy requirement, of which 55% carbohydrate, 15% protein, 60% fat
  • hypercaloric high fat+protein diet with 145% energy requirement, of which 55% carbohydrate, 30% protein, 60% fat

Measurements performed after 6 days on each diet include

  • intrahepatic and intramyocellular lipids (1H-MRS)
  • hepatic and whole body insulin sensitivity (hyperinsulinemic-euglycemic clamp)
  • body weight
  • plasma concentrations of hormones and substrates
  • gene expression profile in skeletal muscle (vastus lateralis) and adipose tissue (subcutaneous abdominal)
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Metabolic Syndrome X
  • Liver Diseases
Other: diet intervention
controled hypercalori high fructose, high fat, or high fat/high protein diet
  • Experimental: normal weight male high fructose diet
    Normal weight subjects on a 6 day- high fructose diet
    Intervention: Other: diet intervention
  • Experimental: offsprings of T2DM high fructose diet
    Healthy non-obese offsprings of patients with type 2 diabetes on a 6-day high fructose diet
    Intervention: Other: diet intervention
  • Experimental: normal weight subjects high fat diet
    healthy male subjects on a 4-day high fat diet
    Intervention: Other: diet intervention
  • Experimental: Normal weight high fat+protein diet
    subjects on a 4-day high fat+protein diet
    Intervention: Other: diet intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
January 2009
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females
  • Age 18-40
  • Informed consent obtained
  • Subgroup with overweight (body mass index [BMI] > 25)
  • Subgroup with family history of type 2 diabetes mellitus

Exclusion Criteria:

  • Smokers
  • Alcohol intake > 30g/day
  • Drug abuse
  • Diabetes mellitus
  • Any concurrent medication
  • Having a pacemaker
  • History of orthopedic surgery
  • History of metal foreign bodies
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00523562
protocol 140/04/CE/FBM
No
Prof. L uc Tappy, Department of Physiology, University of Lausanne
University of Lausanne
Not Provided
Principal Investigator: Luc Tappy, MD University of Lausanne
University of Lausanne
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP