Splanchnic and Systemic VLDL-TG and FFA Balance

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04292977

Enrollment

Registered

2020-03-03

Start date

2018-12-01

Completion date

2022-05-01

Last updated

2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD, NASH - Nonalcoholic Steatohepatitis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

40 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Denmark

Outcome results