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

Liver Diseases Clinical Trial

— MACRONUTR  

Official title:

Study of the Role of Insulin Resistance in the Pathogenesis of the Metabolic Syndrome and of Non-alcoholic Steatohepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523562
• Other study ID #: protocol 140/04/CE/FBM
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: January 2009

Study information

• Verified date: June 2018
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Liver Diseases
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• diet intervention
controlled hypercaloric high fructose, high fat, or high fat/high protein diet

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma triglycerides		6 days
Primary	intra-hepatic lipids		6 days
Primary	insulin mediated glucose disposal		6 days
Secondary	lipid oxidation		6 days
Secondary	plasma beta-hydroxybutyrate		6 days
Secondary	gene expression in skeletal muscle and adipose tissue		6 days