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NCT04292977 Clinical Trial

Splanchnic and Systemic VLDL-TG and FFA Balance

NAFLD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04292977
Other study ID # Jeyanthini
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date May 1, 2022

Study information
Verified date May 2022
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date May 1, 2022
Est. primary completion date November 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • NAFLD
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Locations
Country Name City State
Denmark Arhus University Hospital Department of Endocrinology and Internal Medicine Skejby, Aarhus N, Denmark, 8200 Skejby Aarhus N

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Splanchnic and systemic VLDL-TG and FFA balance in individuals with biopsy proven NAFL or NASH splanchnic (liver) VLDL-TG and FFA uptake and secretion, in individuals with biopsy proven NAFL or NASH 2 years
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