Skip to main content
OpenTrials
Completed

NCT Number: NCT04292977

Splanchnic and Systemic VLDL-TG and FFA Balance

To determine differences between NAFLD and NASH subjects with respect to hepatic FA metabolism (uptake, oxidation, and re-esterification) and hepatic VLDL-TG secretion and peripheral kinetics (oxidation and tissue storage). 8 non-diabetic upper-body obese subjects with NAFLD and 8 with NASH (biopsy proven) will be studied in the overnight fasted state. VLDL-TG stable isotope will be used in combination with hepatic vein catherization to directly measure splanchnic VLDL-TG uptake and secretion. FFA (palmitate) tracers as well as adipose tissue and skeletal muscle biopsies will be used to measure whole-body substrate turnover and flexibility as well as tissue specific substrate handling during fasting and hyperinsulinemic conditions.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases NASH - Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease

Age range

40 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Arhus University Hospital Department of Endocrinology and Internal Medicine Skejby, Aarhus N, Denmark, 8200

Skejby, Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI > 28).
  • 8 obese subject men with NASH (MR spectroskopi, fibro scanner) (BMI > 28). age between 40-70 years. Written consent before the start of the study.

Exclusion criteria

  • known current disease
  • fixed medical drug consumption except antihypertensive drugs and statins. However, pause statins 3 weeks before the examination date Blood donation within the last 3 months prior to the study Participation in experiments involving radioactive isotopes within the last 3 months Alcohol abuse (over 21 items per week for men and 14 for women) Smoking Weight over 130 kg Cancer patients Large intake of medication

Treatment and study plan

Primary outcomes

  1. Splanchnic and systemic VLDL-TG and FFA balance in individuals with biopsy proven NAFL or NASH

    Time frame: 2 years

    splanchnic (liver) VLDL-TG and FFA uptake and secretion, in individuals with biopsy proven NAFL or NASH

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Splanchnic and Systemic VLDL-TG and FFA Balance in Individuals With NAFL and NASH

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Mar 3, 2020
Registry last updated
May 24, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.