Splanchnic and Systemic VLDL-TG and FFA Balance

NCT ID: NCT04292977

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-05-01

Brief Summary

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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

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Conditions

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NAFLD NASH - Nonalcoholic Steatohepatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Skejby, Aarhus N, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38901559 (View on PubMed)

Other Identifiers

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Jeyanthini

Identifier Type: -

Identifier Source: org_study_id

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