Splanchnic and Systemic VLDL-TG and FFA Balance

Completed

• Conditions: NAFLD; NASH - Nonalcoholic Steatohepatitis

• Registration Number: NCT04292977
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Primary Completion: 2020-11-15
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Splanchnic and systemic VLDL-TG and FFA balance in individuals with biopsy proven NAFL or NASH	2 years	splanchnic (liver) VLDL-TG and FFA uptake and secretion, in individuals with biopsy proven NAFL or NASH

Trial Locations

Locations (1)

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