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

Not Applicable

Completed

• Conditions: Metabolic Syndrome X; Liver Diseases

• Registration Number: NCT00523562
• Lead Sponsor: University of Lausanne

Brief 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).

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)

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-08-30
• Study First Submitted QC: 2007-08-30
• Study First Posted: 2007-08-31
• Primary Completion: 2008-04
• Study Completion: 2009-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
plasma triglycerides	6 days
intra-hepatic lipids	6 days
insulin mediated glucose disposal	6 days

Secondary Outcome Measures

Name	Time	Method
lipid oxidation	6 days
plasma beta-hydroxybutyrate	6 days
gene expression in skeletal muscle and adipose tissue	6 days

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland