Non-alcoholic Fatty Liver DiseaseNCT02176811
Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease
An observational study of Non-alcoholic Fatty Liver Disease, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
The study searched for answers to two questions: 1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls. 2. Is there any relationship between plasma betatropin levels and different stage of non-alcoholic fatty liver disease 2.Is there any relationship between… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2009to Feb 2014
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Outpatient clinics of gastroenterology
Who may be able to join
- Patients with biopsy proven non-alcoholic fatty liver disease
Who cannot join
- Taking any drugs
- >20 gr/day alcohol consumption
- chronic metabolic diseases
- morbid obesity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, 06018
About this study
Official title: The Cross Sectional Study to Investigate the Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease and Healthy Controls
The study searched for answers to two questions:
1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls.
- Is there any relationship between plasma betatropin levels and different stage of non-alcoholic fatty liver disease 2.Is there any relationship between plasma betatropin levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Non-alcoholic Fatty Liver Disease, Betatrophin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
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 |
|---|---|---|
| Non-alcoholic Fatty Liver Disese | no treatment | |
| healthy controls | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2009
- Primary completionJun 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Sonmez, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176811
- Sponsor's protocol ID
- GSM-052014
- Status last verified
- May 2014
- First submitted
- 22 Jun 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cross Sectional Study to Investigate the Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease and Healthy Controls
- ClinicalTrials.gov ID
- NCT02176811
- Acronym / sponsor ID
- GSM-052014
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Non-alcoholic Fatty Liver Disease, Betatrophin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Jun 2014 (estimated)
- 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.
The study searched for answers to two questions:
1-What are the plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls.
- Is there any relationship between plasma betatropin levels and different stage of non-alcoholic fatty liver disease 2.Is there any relationship between plasma betatropin levels and metabolic parameters in subjects with non-alcoholic fatty liver disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-alcoholic Fatty Liver Disese | – | –no treatment |
| healthy controls | – | –no treatment |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Outpatient clinics of gastroenterology
Key inclusion criteria (1 listed)
- Patients with biopsy proven non-alcoholic fatty liver disease
Key exclusion criteria (4 listed)
- Taking any drugs
- >20 gr/day alcohol consumption
- chronic metabolic diseases
- morbid obesity
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
Plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls.
Time frame: 6 months
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 27 Jun 2014.
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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 Non-alcoholic Fatty Liver Disease, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 27 Jun 2014. 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 Turkey (Türkiye). 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?
Plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls. (time frame: 6 months). 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 27 Jun 2014.