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
  Purpose

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).


Condition Intervention
Metabolic Syndrome X
Liver Diseases
Other: diet intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of the Role of Insulin Resistance in the Pathogenesis of the Metabolic Syndrome and of Non-alcoholic Steatohepatitis

Resource links provided by NLM:


Further study details as provided by University of Lausanne:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 41
Study Start Date: July 2006
Study Completion Date: January 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: normal weight male high fructose diet
Normal weight subjects on a 6 day- high fructose diet
Other: diet intervention
controled hypercalori high fructose, high fat, or high fat/high protein diet
Experimental: offsprings of T2DM high fructose diet
Healthy non-obese offsprings of patients with type 2 diabetes on a 6-day high fructose diet
Other: diet intervention
controled hypercalori high fructose, high fat, or high fat/high protein diet
Experimental: normal weight subjects high fat diet
healthy male subjects on a 4-day high fat diet
Other: diet intervention
controled hypercalori high fructose, high fat, or high fat/high protein diet
Experimental: Normal weight high fat+protein diet
subjects on a 4-day high fat+protein diet
Other: diet intervention
controled hypercalori high fructose, high fat, or high fat/high protein diet

Detailed Description:

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)
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523562

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
University of Lausanne
Investigators
Principal Investigator: Luc Tappy, MD University of Lausanne
  More Information

No publications provided by University of Lausanne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. L uc Tappy, Department of Physiology, University of Lausanne
ClinicalTrials.gov Identifier: NCT00523562     History of Changes
Other Study ID Numbers: protocol 140/04/CE/FBM
Study First Received: August 30, 2007
Last Updated: October 27, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne:
fructose
dietary lipids
dietary proteins
hepatic steatosis
insulin resistance
Healthy humans
overweight humans
obese humans

Additional relevant MeSH terms:
Insulin Resistance
Liver Diseases
Metabolic Syndrome X
Syndrome
Digestive System Diseases
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Pathologic Processes
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014