Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods

Institute for Clinical and Experimental Medicine

Status: Completed

Conditions: Hepatic Fat Content

Treatments: Dietary Supplement: Fructose; Dietary Supplement: Fat; Dietary Supplement: Fasting; Dietary Supplement: Fat+Glucose; Dietary Supplement: Glucose; Dietary Supplement: Fat+Fructose

Study type: Interventional

Funder types: Other

Identifiers

NCT03680248

G285

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 12 patient groups

Healthy subjects, Fat

Experimental group

Description:

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load intervention

Treatment:

Dietary Supplement: Fat

Steatosis, Fat

Experimental group

Description:

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load intervention

Treatment:

Dietary Supplement: Fat

Healthy subjects, Fasting

Other group

Description:

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fasting

Treatment:

Dietary Supplement: Fasting

Steatosis, Fasting

Other group

Description:

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fasting

Treatment:

Dietary Supplement: Fasting

Healthy subjects, Fat+Glucose

Experimental group

Description:

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + glucose administration

Treatment:

Dietary Supplement: Fat+Glucose

Steatosis, Fat+Glucose

Experimental group

Description:

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + glucose administration

Treatment:

Dietary Supplement: Fat+Glucose

Healthy subjects, Glucose

Experimental group

Description:

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - glucose administration

Treatment:

Dietary Supplement: Glucose

Steatosis, Glucose

Experimental group

Description:

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - glucose administration

Treatment:

Dietary Supplement: Glucose

Healthy subjects, Fat+Fructose

Experimental group

Description:

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + fructose administration

Treatment:

Dietary Supplement: Fat+Fructose

Steatosis, Fat+Fructose

Experimental group

Description:

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + fructose administration

Treatment:

Dietary Supplement: Fat+Fructose

Healthy subjects, Fructose

Experimental group

Description:

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fructose administration

Treatment:

Dietary Supplement: Fructose

Steatosis, Fructose

Experimental group

Description:

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fructose administration

Treatment:

Dietary Supplement: Fructose