Non Alcoholic Fatty Liver DiseaseNCT01874249
Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease
A study testing Electronic detailed information, NAFLD Score and Transient elastography in people with Non Alcoholic Fatty Liver Disease, run by Fundación Clínica Médica Sur at 1 site in Mexico.
Trial summary
The purpose of this randomized clinical trial is to evaluate the utility of noninvasive markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- Electronic detailed information, NAFLD Score and Transient elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2012to Aug 2016
- Phase
- Interventional
- 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 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with BMI ≥ 27 Kg/m2 and any stage of non alcoholic fatty liver, diagnosed by ultrasound.
Who cannot join
- Patients with other liver disease.
- Patients under treatment with tamoxifen, methotrexate, amiodarone, diltiazem or other drugs able to induce fatty liver.
- Patients with alcohol consumption greater than 140 gr. per week
- Patients who have received blood transfusion before 1990
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Detect Advanced Fibrosis by Non-invasive Methods in Subjects With Non-alcoholic Fatty Liver Disease
The purpose of this randomized clinical trial is to evaluate the utility of noninvasive markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound.
The primary objective is to determine the effectiveness of noninvasive markers for detect of advanced fibrosis in patients with diagnosis of fatty liver disease.
The secondary objectives are:
- To determine the increase in health care with the specialist (gastroenterologist or endocrinologist).
- To determine which noninvasive evaluation strategy favors any treatment of fatty liver disease.
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- Electronic detailed information, NAFLD Score, Transient elastography
- Keywords
- Hepatic fibrosis, Steatosis, Noninvasive markers.
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic detailed informationOther
Electronic detailed information about non alcoholic fatty liver disease.
NAFLD ScoreOther
diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854
Transient elastographyOther
Transient elastography values greater than 8 kPa
| Study group | Role | What they receive |
|---|---|---|
| Electronic detailed information | Experimental | Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease. Receives: Other: Electronic detailed information |
| NAFLD Score | Experimental | Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score. Receives: Other: Electronic detailed information; Other: NAFLD Score |
| NAFLD Score plus Transient elastography | Experimental | Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score and transient elastography. Receives: Other: Electronic detailed information; Other: NAFLD Score; Other: Transient elastography |
| Transient elastography | Experimental | Standard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by transient elastography. Receives: Other: Electronic detailed information; Other: Transient elastography |
| Standard of care | No intervention | Standard of care for patients with diagnosis of fatty liver by ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced Fibrosis by any diagnostic modality
Evidence of advanced fibrosis, diagnosed by transient elastography (greater than 8 kPa), NAFLD Score above 0.675, liver biopsy or any other non-invasive marker of liver fibrosis.
Measured: One year after the diagnosis of steatosis.
Secondary outcomes (1)
Specialized care
Through telephone follow-up, investigate if the patient attends to gastroenterologist or endocrinologist for examination, diagnostic confirmation or any treatment.
Measured: One year after the diagnosis of steatosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionAug 2015
- Study completionAug 2016
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Clínica Médica Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norberto Carlos Chavez Taia, Fundación Clínica Médica Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874249
- Sponsor's protocol ID
- FAFLD
- Status last verified
- Aug 2018
- First submitted
- 5 Jun 2013
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chavez-Tapia NC, Barrientos-Gutierrez T, Torres-Ibarra L, Sanchez-Jimenez B, Juarez-Hernandez E, Ramos-Ostos M, Alva-Lopez LF, Uribe M. Incremental levels of diagnostic information incentivize health-seeking in non-alcoholic fatty liver: a randomized clinical trial. Sci Rep. 2022 May 18;12(1):8272. doi: 10.1038/s41598-022-12295-1.
PubMed 35585153
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Detect Advanced Fibrosis by Non-invasive Methods in Subjects With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01874249
- Acronym / sponsor ID
- FAFLD
- Conditions
- Non Alcoholic Fatty Liver Disease
- Keywords
- Hepatic fibrosis, Steatosis, Noninvasive markers.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Fundación Clínica Médica SurUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Jun 2013 (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 purpose of this randomized clinical trial is to evaluate the utility of noninvasive markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound.
The primary objective is to determine the effectiveness of noninvasive markers for detect of advanced fibrosis in patients with diagnosis of fatty liver disease.
The secondary objectives are:
- To determine the increase in health care with the specialist (gastroenterologist or endocrinologist).
- To determine which noninvasive evaluation strategy favors any treatment of fatty liver disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Electronic detailed information | Experimental | Other: Electronic detailed informationStandard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease. |
| NAFLD Score | Experimental | Other: Electronic detailed information, Other: NAFLD ScoreStandard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score. |
| NAFLD Score plus Transient elastography | Experimental | Other: Electronic detailed information, Other: NAFLD Score, Other: Transient elastographyStandard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by NAFLD score and transient elastography. |
| Transient elastography | Experimental | Other: Electronic detailed information, Other: Transient elastographyStandard of care for patients with diagnosis of fatty liver by ultrasound, plus electronic detailed information about non alcoholic fatty liver disease, plus diagnosis of advanced fibrosis by transient elastography. |
| Standard of care | No intervention | –Standard of care for patients with diagnosis of fatty liver by ultrasound. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with BMI ≥ 27 Kg/m2 and any stage of non alcoholic fatty liver, diagnosed by ultrasound.
Key exclusion criteria (4 listed)
- Patients with other liver disease.
- Patients under treatment with tamoxifen, methotrexate, amiodarone, diltiazem or other drugs able to induce fatty liver.
- Patients with alcohol consumption greater than 140 gr. per week
- Patients who have received blood transfusion before 1990
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic detailed informationElectronic detailed information about non alcoholic fatty liver disease. | Other | Electronic detailed information, NAFLD Score, NAFLD Score plus Transient elastography, Transient elastography |
| NAFLD Scorediagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854 | Other | NAFLD Score, NAFLD Score plus Transient elastography |
| Transient elastographyTransient elastography values greater than 8 kPa | Other | NAFLD Score plus Transient elastography, Transient elastography |
Primary outcome
Advanced Fibrosis by any diagnostic modality
Time frame: One year after the diagnosis of steatosis.
Evidence of advanced fibrosis, diagnosed by transient elastography (greater than 8 kPa), NAFLD Score above 0.675, liver biopsy or any other non-invasive marker of liver fibrosis.
1 secondary outcome
Specialized care
Time frame: One year after the diagnosis of steatosis.
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 9 Aug 2018.
- Derived from this study: PubMed 35585153Chavez-Tapia NC, Barrientos-Gutierrez T, Torres-Ibarra L, Sanchez-Jimenez B, Juarez-Hernandez E, Ramos-Ostos M, Alva-Lopez LF, Uribe M. Incremental levels of diagnostic information incentivize health-seeking in non-alcoholic fatty liver: a randomized clinical trial. Sci Rep. 2022 May 18;12(1):8272. doi: 10.1038/s41598-022-12295-1.
Related trials for Non Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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?
A study testing Electronic detailed information, NAFLD Score and Transient elastography in people with Non Alcoholic Fatty Liver Disease, run by Fundación Clínica Médica Sur at 1 site in Mexico.
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 9 Aug 2018. 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 Mexico. 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?
Advanced Fibrosis by any diagnostic modality (time frame: One year after the diagnosis of steatosis.). 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 NCT01874249, 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 9 Aug 2018.