NAFLDLINANCT06357052
The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
An observational study of NAFLD and Urinary Lithiasis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Urinary Lithiasis
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jul 2019to 30 Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 subjects suffering from NAFLD histologically ascertained by routine liver biopsy performed at the P.O. liver surgeries Columbus relating to the Gastroenterology Area Units.
Who may be able to join
- subject >= 18 years old
- able to sign the ICF
- Liver biopsy with report compatible with NAFLD
Who cannot join
- alchol use > 20g/die
- other causes of liver disease
- active neoplasm
Trial locations and contacts
1 site in 1 country.
About this study
Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation.
- Conditions
- NAFLD, Urinary Lithiasis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NAFLD patients without liver cirrhosis (NLCs, n = 28) | Not described | |
| NAFLD patients with liver cirrhosis (LCs, n = 14) | Not described | |
| healthy individuals (HIs, n = 12) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the analysis of the correlation between the degree of severity of NAFLD And urinary lithogenic profilecharacterized by reduced urinary magnesium and altered urinary ammonium excretion.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start19 Jul 2019
- Primary completion30 Apr 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357052
- Sponsor's protocol ID
- 2701
- Acronym
- LINA
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT06357052
- Acronym / sponsor ID
- LINA / 2701
- Conditions
- NAFLD, Urinary Lithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 10 Apr 2024 (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.
Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NAFLD patients without liver cirrhosis (NLCs, n = 28) | – | – |
| NAFLD patients with liver cirrhosis (LCs, n = 14) | – | – |
| healthy individuals (HIs, n = 12) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 subjects suffering from NAFLD histologically ascertained by routine liver biopsy performed at the P.O. liver surgeries Columbus relating to the Gastroenterology Area Units.
Key inclusion criteria (3 listed)
- subject >= 18 years old
- able to sign the ICF
- Liver biopsy with report compatible with NAFLD
Key exclusion criteria (3 listed)
- alchol use > 20g/die
- other causes of liver disease
- active neoplasm
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
the analysis of the correlation between the degree of severity of NAFLD And urinary lithogenic profilecharacterized by reduced urinary magnesium and altered urinary ammonium excretion.
Time frame: 15 years
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 10 Apr 2024.
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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 Urinary Lithiasis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 3 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 10 Apr 2024. 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 Italy. 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?
the analysis of the correlation between the degree of severity of NAFLD And urinary lithogenic profilecharacterized by reduced urinary magnesium and altered urinary ammonium excretion. (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2024.