Splanchnic and Systemic VLDL-TG and FFA Balance

NCT04292977 | Completed

• 1 other identifier: Jeyanthini
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Skejby, Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Risikesan J, Heeboll S, Kumarathas I, Sondergaard E, Johansen RF, Ringgaard S, Aagaard NK, Sandahl TD, Villadsen GE, Gormsen LC, Frystyk J, Jensen MD, Gronbaek H, Nielsen S. Similar insulin regulation of splanchnic FFA and VLDL-TG in men with nonalcoholic hepatic steatosis and steatohepatitis. J Lipid Res. 2024 Jul;65(7):100580. doi: 10.1016/j.jlr.2024.100580. Epub 2024 Jun 18.

  PMID: 38901559 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: December 1, 2018
• Primary Completion: November 15, 2020
• Study Completion: May 1, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

DK (1)