Clinical trial NCT03680248: Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods
Official title: Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Fat Content
Keywords: hepatic fat content
dietary fat
glucose
fructose
non-esterified fatty acid
triglyceride
insulin
postprandial period
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2018-09-21
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 10 non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) and 10 non-obese non-diabetic subjects with increased hepatic fat content (more than 5% of hepatic fat) will undergo series of six experiments - changes of liver fat content will be measured at time 0, 3 and 6 hours after specific dietary interventions
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hepatic fat content
timeFrame: Before time 0 hour, 3 hours, 6 hours
Secondary outcomes:
measure: TG
timeFrame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
measure: NEFA
timeFrame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
measure: Glucose
timeFrame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
measure: Insulin
timeFrame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
measure: Glucagon
timeFrame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours
Other outcomes:
Locations:
city: Prague 4
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
affiliation: Institute for Clinical and Experimental Medicine
name: Milan Hajek, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dusilova T, Kovar J, Drobny M, Sedivy P, Dezortova M, Poledne R, Zemankova K, Hajek M. Different acute effects of fructose and glucose administration on hepatic fat content. Am J Clin Nutr. 2019 Jun 1;109(6):1519-1526. doi: 10.1093/ajcn/nqy386.