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Completed

NCT Number: NCT03680248

Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods

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.

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Key information

Conditions

Hepatic Fat Content Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fat

Dietary Supplement

Subjects will consume dairy cream (150 g of fat) at time 0 hours.

fasting

Dietary Supplement

Subjects will fast throughout the experiment.

Fat+Glucose

Dietary Supplement

Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of glucose.

Glucose

Dietary Supplement

Subjects will drink herbal tea containing 50 g of glucose at times 0, 2 and 4 hours.

Fat+Fructose

Dietary Supplement

Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of fructose.

Fructose

Dietary Supplement

Subjects will drink herbal tea containing 50 g of fructose at times 0, 2 and 4 hours.

Primary outcomes

  1. Hepatic fat content

    Time frame: 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 outcomes

  1. TG

    Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

    Plasma triglyceride concentration

  2. NEFA

    Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

    Plasma non-esterified fatty-acid concentration

  3. Glucose

    Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

    Plasma glucose concentration

  4. Insulin

    Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

    Plasma insulin concentration

  5. Glucagon

    Time frame: before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

    Plasma glucagon concentration

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 21, 2018
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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