NAFLDNCT04292977
Splanchnic and Systemic VLDL-TG and FFA Balance
An observational study of NAFLD and NASH - Nonalcoholic Steatohepatitis, run by University of Aarhus at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- NAFLD, NASH - Nonalcoholic Steatohepatitis
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2018to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Arhus University Hospital Department of Endocrinology and Internal Medicine Skejby, Aarhus N, Denmark, 8200
Skejby, Aarhus N, 8200
About this study
Official title: 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.
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Dec 2018
- Primary completion15 Nov 2020
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292977
- Sponsor's protocol ID
- Jeyanthini
- Status last verified
- May 2022
- First submitted
- 28 Feb 2020
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38901559
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splanchnic and Systemic VLDL-TG and FFA Balance in Individuals With NAFL and NASH
- ClinicalTrials.gov ID
- NCT04292977
- Acronym / sponsor ID
- Jeyanthini
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Splanchnic and systemic VLDL-TG and FFA balance in individuals with biopsy proven NAFL or NASH
Time frame: 2 years
splanchnic (liver) VLDL-TG and FFA uptake and secretion, in individuals with biopsy proven NAFL or NASH
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 38901559Risikesan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD and NASH - Nonalcoholic Steatohepatitis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Splanchnic and systemic VLDL-TG and FFA balance in individuals with biopsy proven NAFL or NASH (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.