Splanchnic and Systemic VLDL-TG and FFA Balance

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

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.

Study Overview

• Status: Completed
• Conditions: NAFLD; NASH - Nonalcoholic Steatohepatitis

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): November 15, 2020
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Jeyanthini

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No