Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods

Not Applicable

Completed

• Conditions: Hepatic Fat Content
• Interventions: Dietary Supplement: Fasting; Dietary Supplement: Glucose; Dietary Supplement: Fat; Dietary Supplement: Fat+Glucose; Dietary Supplement: Fructose; Dietary Supplement: Fat+Fructose

• Registration Number: NCT03680248
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief Summary

The first primary research objective of the study is to determine whether high-fat load (150 g of fat) induces increase in hepatic fat content (HFC) three and six hours after meal in insulin-sensitive subjects with normal HFC (\<5% of fat) and in non-diabetic subjects with an increased HFC (\>5% of fat). Furthermore, the other objective of the study is to determine whether the response of HFC to a high-fat load is affected by coadministration of glucose or fructose.

Detailed Description

The epidemic of non-alcoholic fatty liver disease (NAFLD) is becoming a major challenge faced by health system worldwide. The hepatic fat comes from the major sources - non-esterified fatty acids (NEFA) released from adipose tissue, dietary fat and de novo lipogenesis. Fat accumulation in the liver then occurs when triglycerides (TG) that are formed are not rapidly enough oxidized or secreted from the liver in very low density lipoproteins (VLDL). It can be hypothesized that the capacity of the liver to eliminate TG can be overcome after high load of dietary fat. High-fat load should induce an immediate accumulation of hepatic fat that could be detected using 1H magnetic resonance spectroscopy (1H-MRS). The accumulation of liver fat can be also affected by coadministration of simple carbohydrates - glucose and fructose. The administration of these carbohydrates can have a pronounced impact on the availability of particular sources of hepatic fat.

Study Timeline

• Study Start: 2016-04-26
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-12
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

• normal response to oral glucose tolerance test
• normal glycated hemoglobin
• normal aspartate aminotransferase (AST)
• normal alanine aminotransferase (ALT)

Exclusion Criteria

• BMI > 30 kg/m2
• use of pharmacological agents affecting insulin sensitivity
• use of pharmacological agents affecting lipid metabolism
• inability to undergo 1H-MRS examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subjects, Fasting	Fasting	non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fasting
Healthy subjects, Glucose	Glucose	non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - glucose administration
Steatosis, Fat	Fat	non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load intervention
Steatosis, Fasting	Fasting	non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fasting
Healthy subjects, Fat+Glucose	Fat+Glucose	non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + glucose administration
Healthy subjects, Fat	Fat	non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load intervention
Steatosis, Glucose	Glucose	non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - glucose administration
Healthy subjects, Fructose	Fructose	non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fructose administration
Steatosis, Fat+Glucose	Fat+Glucose	non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + glucose administration
Healthy subjects, Fat+Fructose	Fat+Fructose	non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + fructose administration
Steatosis, Fructose	Fructose	non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fructose administration
Steatosis, Fat+Fructose	Fat+Fructose	non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + fructose administration

Primary Outcome Measures

Name	Time	Method
Hepatic fat content	Before time 0 hour, 3 hours, 6 hours	Change in hepatic fat content as determined by proton magnetic resonance spectroscopy (%) between 0 and 6 hours

Secondary Outcome Measures

Name	Time	Method
Insulin	before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours	Plasma insulin concentration
TG	before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours	Plasma triglyceride concentration
NEFA	before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours	Plasma non-esterified fatty-acid concentration
Glucose	before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours	Plasma glucose concentration
Glucagon	before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours	Plasma glucagon concentration

Trial Locations

Locations (1)

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague 4, Czechia