Type 2 DiabetesNCT06694974
Liver Fibrosis Assessment in Diabetic Patients
A study testing APP calculation for FIB-4 in people with Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators plan to use the smartphone App for FIB-4 calculation and increase the awareness of liver fibrosis. These patients might notify and discuss with the physician of their liver fibrosis severity to improve the identification, and management of liver fibrosis. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- APP calculation for FIB-4
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients, regular follow-up in OPD every 3 months
- Age 35-65 (Because FIB-4 is not accurate in people with age <35 or > 65)
Who cannot join
- Patients are regularly follow the investigators at the liver clinic for liver disease
- Active malignancy
- Hematology disease with thrombocytopenia
- Pregnant patients with type 2 diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial for Liver Fibrosis Assessment in Diabetic Patients
The investigators plan to use the smartphone App for FIB-4 calculation and increase the awareness of liver fibrosis. These patients might notify and discuss with the physician of their liver fibrosis severity to improve the identification, and management of liver fibrosis. This is to establish a patient-centered clinical pathway to identify patients with advanced fibrosis in type 2 diabetes patients. The investigators plan to conduct this randomized controlled trial of two groups: FIB-4 APP group and the standard care group. The primary end point is the referral rate of patients with advanced fibrosis (FIB-4 ≥ 2.67).
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in people with type 2 diabetes. Patients with prediabetes/type 2 diabetes or 2 or more metabolic risk factors are at higher risk for hepatic fibrosis. Type 2 diabetes increases the risk of cirrhosis, cirrhotic complications and liver-related mortality. According to the American Gastroenterology Association guideline, NAFLD screening should be considered for individuals older than 40 years with type 2 diabetes mellitus.
The American diabetes association now advises screening all adults with type 2 diabetes or prediabetes, particularly those with obesity or cardiometabolic risk factors or established cardiovascular disease for clinically significant liver fibrosis (defined as moderate fibrosis to cirrhosis) using a calculated fibrosis-4 index (FIB-4), even those with normal liver enzyme levels.4 People with type 1 diabetes who have obesity, hepatic steatosis, or elevated aminotransferases should also screen for NAFLD. The recommended screening tool is the fibrosis-4 index (FIB-4), a calculation that includes the patient's age, liver enzyme levels, and platelet counts. A score of 1.3 or higher is considered high risk for clinically significant fibrosis, and above 2.67 is very high-risk.
According to a recent study of 1918 patients who received screening Fibroscan, 72.8% had steatosis, and 17.1% had advanced fibrosis (Fibroscan >= 9.6kpa). In another study in Malaysia, among 557 type 2 DM patients who received Fibroscan, 72.4% had NAFLD, and 21% had advanced fibrosis(Fibroscan >= 9.6kpa). Another study screened 561 type 2 diabetes patients in the US, 70% had steatosis, and 9% had advanced fibrosis (Fibroscan >= 9.7kpa). Overall, the prevalence of steatotic liver disease is 70%, and the percentage of advanced fibrosis (>=F3) is 9-21%.
However, the screening of NAFLD in type 2 diabetes patients are underutilized. Because there is still a significant knowledge gap in the clinicians for the identification, diagnosis, and management of NAFLD. There is no country had a national or subnational strategy for NAFLD. Several clinical pathways to facilitate the evaluation of NAFLD in type 2 diabetes patients are developing now. Instead of relying on active assessment by clinicians, automated fibrosis score calculation using the FIB-4 index followed by reminder messages in the electronic clinical management system increased appropriate referral for hepatology assessment or further fibrosis tests in patients with increased fibrosis scores from 3.1% to 33.3%. However, there is still more than 2/3 of patients was not referred for further fibrosis evaluation.
The electronic notification system is not widely available for all clinics, while nearly every patient has the mobile phone. Applying the notification system through the smartphone APP is beneficial for the patients to participate actively for their personal health management and improving disease awareness.
The investigators plan to use the smartphone App for FIB-4 calculation and increase the awareness of liver fibrosis. These patients might notify and discuss with the physician of their liver fibrosis severity to improve the identification, and management of liver fibrosis. This is to establish a patient-centered clinical pathway to identify patients with advanced fibrosis in type 2 diabetes patients. The investigators plan to conduct this randomized controlled trial of two groups: FIB-4 APP group and the standard care group. The primary end point is the referral rate of patients with advanced fibrosis (FIB-4 ≥ 2.67).
- Being tested
- APP calculation for FIB-4, Standard Care (in control arm)
- Keywords
- Type 2 diabetes patients, metabolic dysfunction-associated steatotic liver disease
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP calculation for FIB-4Behavioural
the investigators plan to use the smartphone App for FIB-4 calculation and notify the patients.
Standard Care (in control arm)Behavioural
The standard group proceeds as regular practice
| Study group | Role | What they receive |
|---|---|---|
| FIB-4 APP group | Experimental | Not described Receives: Behavioral: APP calculation for FIB-4 |
| standard group | Other | Not described Receives: Behavioral: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hepatology clinic referral rate if FIB-4 ≥ 2.67 (advanced fibrosis, F3)
Number of patients with FIB-4 ≥ 2.67 being referred to hepatology clinic, divided by total number of patients with FIB-4 ≥ 2.67.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
The percentage of patients examined by Fibroscan in each group with FIB4≥2.67
The number of patients with a FIB-4 ≥ 2.67 and received the fibroscan test, divided by the total number of patients with a FIB-4 ≥ 2.67
Measured: through study completion, an average of 1 year
The hepatology clinic referral rate if FIB-4 ≥ 1.3 and <2.67 in individual groups
The number of patients with FIB-4 ≥ 1.3 and <2.67 and referred to the hepatology clinic, divided by the total number of patients with FIB-4 ≥ 1.3 and <2.67
Measured: through study completion, an average of 1 year
Incidence rate of liver cirrhosis in individual groups
Patients diagnosed with liver cirrhosis clinically, divided by the total number of patients in the individual group
Measured: through study completion, an average of 1 year
The hepatology clinic referral rate of patients with FIB-4 <1.3 in individual groups
The number of patients with FIB-4 <1.3 and referred to hepatology clinic, divided by the total number of patients with FIB-4 <1.3
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start22 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tung Hung Su, MD, PhD, Principal investigator, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694974
- Sponsor's protocol ID
- 202408147RINA
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the patients' privacy information.
Publications
Zhang X, Yip TC, Wong GL, Leow WX, Liang LY, Lim LL, Li G, Ibrahim L, Lin H, Lai JCT, Chim AM, Chan HLY, Kong AP, Chan WK, Wong VW. Clinical care pathway to detect advanced liver disease in patients with type 2 diabetes through automated fibrosis score calculation and electronic reminder messages: a randomised controlled trial. Gut. 2023 Nov 24;72(12):2364-2371. doi: 10.1136/gutjnl-2023-330269.
PubMed 37549979Lazarus JV, Mark HE, Villota-Rivas M, Palayew A, Carrieri P, Colombo M, Ekstedt M, Esmat G, George J, Marchesini G, Novak K, Ocama P, Ratziu V, Razavi H, Romero-Gomez M, Silva M, Spearman CW, Tacke F, Tsochatzis EA, Yilmaz Y, Younossi ZM, Wong VW, Zelber-Sagi S, Cortez-Pinto H, Anstee QM; NAFLD policy review collaborators. The global NAFLD policy review and preparedness index: Are countries ready to address this silent public health challenge? J Hepatol. 2022 Apr;76(4):771-780. doi: 10.1016/j.jhep.2021.10.025. Epub 2021 Dec 9.
PubMed 34895743Younossi ZM, Ong JP, Takahashi H, Yilmaz Y, Eguc Hi Y, El Kassas M, Buti M, Diago M, Zheng MH, Fan JG, Yu ML, Wai-Sun Wong V, Alswat K, Chan WK, Mendez-Sanchez N, Burra P, Bugianesi E, Duseja AK, George J, Papatheodoridis GV, Saeed H, Castera L, Arrese M, Kugelmas M, Romero-Gomez M, Alqahtani S, Ziayee M, Lam B, Younossi I, Racila A, Henry L, Stepanova M; Global Nonalcoholic Steatohepatitis Council. A Global Survey of Physicians Knowledge About Nonalcoholic Fatty Liver Disease. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1456-e1468. doi: 10.1016/j.cgh.2021.06.048. Epub 2021 Jul 3.
PubMed 34229038Lomonaco R, Godinez Leiva E, Bril F, Shrestha S, Mansour L, Budd J, Portillo Romero J, Schmidt S, Chang KL, Samraj G, Malaty J, Huber K, Bedossa P, Kalavalapalli S, Marte J, Barb D, Poulton D, Fanous N, Cusi K. Advanced Liver Fibrosis Is Common in Patients With Type 2 Diabetes Followed in the Outpatient Setting: The Need for Systematic Screening. Diabetes Care. 2021 Feb;44(2):399-406. doi: 10.2337/dc20-1997. Epub 2020 Dec 21.
PubMed 33355256Lai LL, Wan Yusoff WNI, Vethakkan SR, Nik Mustapha NR, Mahadeva S, Chan WK. Screening for non-alcoholic fatty liver disease in patients with type 2 diabetes mellitus using transient elastography. J Gastroenterol Hepatol. 2019 Aug;34(8):1396-1403. doi: 10.1111/jgh.14577. Epub 2019 Jan 21.
PubMed 30551263Kwok R, Choi KC, Wong GL, Zhang Y, Chan HL, Luk AO, Shu SS, Chan AW, Yeung MW, Chan JC, Kong AP, Wong VW. Screening diabetic patients for non-alcoholic fatty liver disease with controlled attenuation parameter and liver stiffness measurements: a prospective cohort study. Gut. 2016 Aug;65(8):1359-68. doi: 10.1136/gutjnl-2015-309265. Epub 2015 Apr 14.
PubMed 25873639American Diabetes Association Professional Practice Committee. 4. Comprehensive Medical Evaluation and Assessment of Comorbidities: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S52-S76. doi: 10.2337/dc24-S004.
PubMed 38078591Long MT, Noureddin M, Lim JK. AGA Clinical Practice Update: Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Lean Individuals: Expert Review. Gastroenterology. 2022 Sep;163(3):764-774.e1. doi: 10.1053/j.gastro.2022.06.023. Epub 2022 Jul 14.
PubMed 35842345Castera L, Cusi K. Diabetes and cirrhosis: Current concepts on diagnosis and management. Hepatology. 2023 Jun 1;77(6):2128-2146. doi: 10.1097/HEP.0000000000000263. Epub 2023 Jan 13.
PubMed 36631005Wattacheril JJ, Abdelmalek MF, Lim JK, Sanyal AJ. AGA Clinical Practice Update on the Role of Noninvasive Biomarkers in the Evaluation and Management of Nonalcoholic Fatty Liver Disease: Expert Review. Gastroenterology. 2023 Oct;165(4):1080-1088. doi: 10.1053/j.gastro.2023.06.013. Epub 2023 Aug 4.
PubMed 37542503
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Liver Fibrosis Assessment in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06694974
- Acronym / sponsor ID
- 202408147RINA
- Keywords
- Type 2 diabetes patients, metabolic dysfunction-associated steatotic liver disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Nov 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.
The investigators plan to use the smartphone App for FIB-4 calculation and increase the awareness of liver fibrosis. These patients might notify and discuss with the physician of their liver fibrosis severity to improve the identification, and management of liver fibrosis. This is to establish a patient-centered clinical pathway to identify patients with advanced fibrosis in type 2 diabetes patients. The investigators plan to conduct this randomized controlled trial of two groups: FIB-4 APP group and the standard care group. The primary end point is the referral rate of patients with advanced fibrosis (FIB-4 ≥ 2.67).
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in people with type 2 diabetes. Patients with prediabetes/type 2 diabetes or 2 or more metabolic risk factors are at higher risk for hepatic fibrosis. Type 2 diabetes increases the risk of cirrhosis, cirrhotic complications and liver-related mortality. According to the American Gastroenterology Association guideline, NAFLD screening should be considered for individuals older than 40 years with type 2 diabetes mellitus.
The American diabetes association now advises screening all adults with type 2 diabetes or prediabetes, particularly those with obesity or cardiometabolic risk factors or established cardiovascular disease for clinically significant liver fibrosis (defined as moderate fibrosis to cirrhosis) using a calculated fibrosis-4 index (FIB-4), even those with normal liver enzyme levels.4 People with type 1 diabetes who have obesity, hepatic steatosis, or elevated aminotransferases should also screen for NAFLD. The recommended screening tool is the fibrosis-4 index (FIB-4), a calculation that includes the patient's age, liver enzyme levels, and platelet counts. A score of 1.3 or higher is considered high risk for clinically significant fibrosis, and above 2.67 is very high-risk.
According to a recent study of 1918 patients who received screening Fibroscan, 72.8% had steatosis, and 17.1% had advanced fibrosis (Fibroscan >= 9.6kpa). In another study in Malaysia, among 557 type 2 DM patients who received Fibroscan, 72.4% had NAFLD, and 21% had advanced fibrosis(Fibroscan >= 9.6kpa). Another study screened 561 type 2 diabetes patients in the US, 70% had steatosis, and 9% had advanced fibrosis (Fibroscan >= 9.7kpa). Overall, the prevalence of steatotic liver disease is 70%, and the percentage of advanced fibrosis (>=F3) is 9-21%.
However, the screening of NAFLD in type 2 diabetes patients are underutilized. Because there is still a significant knowledge gap in the clinicians for the identification, diagnosis, and management of NAFLD. There is no country had a national or subnational strategy for NAFLD. Several clinical pathways to facilitate the evaluation of NAFLD in type 2 diabetes patients are developing now. Instead of relying on active assessment by clinicians, automated fibrosis score calculation using the FIB-4 index followed by reminder messages in the electronic clinical management system increased appropriate referral for hepatology assessment or further fibrosis tests in patients with increased fibrosis scores from 3.1% to 33.3%. However, there is still more than 2/3 of patients was not referred for further fibrosis evaluation.
The electronic notification system is not widely available for all clinics, while nearly every patient has the mobile phone. Applying the notification system through the smartphone APP is beneficial for the patients to participate actively for their personal health management and improving disease awareness.
The investigators plan to use the smartphone App for FIB-4 calculation and increase the awareness of liver fibrosis. These patients might notify and discuss with the physician of their liver fibrosis severity to improve the identification, and management of liver fibrosis. This is to establish a patient-centered clinical pathway to identify patients with advanced fibrosis in type 2 diabetes patients. The investigators plan to conduct this randomized controlled trial of two groups: FIB-4 APP group and the standard care group. The primary end point is the referral rate of patients with advanced fibrosis (FIB-4 ≥ 2.67).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIB-4 APP group | Experimental | Behavioral: APP calculation for FIB-4 |
| standard group | Other | Behavioral: Standard Care (in control arm) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes patients, regular follow-up in OPD every 3 months
- Age 35-65 (Because FIB-4 is not accurate in people with age <35 or > 65)
Key exclusion criteria (4 listed)
- Patients are regularly follow the investigators at the liver clinic for liver disease
- Active malignancy
- Hematology disease with thrombocytopenia
- Pregnant patients with type 2 diabetes
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 |
|---|---|---|
| APP calculation for FIB-4the investigators plan to use the smartphone App for FIB-4 calculation and notify the patients. | Behavioural | FIB-4 APP group |
| Standard Care (in control arm)The standard group proceeds as regular practice | Behavioural | standard group |
Primary outcome
The hepatology clinic referral rate if FIB-4 ≥ 2.67 (advanced fibrosis, F3)
Time frame: through study completion, an average of 1 year
Number of patients with FIB-4 ≥ 2.67 being referred to hepatology clinic, divided by total number of patients with FIB-4 ≥ 2.67.
4 secondary outcomes
The percentage of patients examined by Fibroscan in each group with FIB4≥2.67
Time frame: through study completion, an average of 1 year
The hepatology clinic referral rate if FIB-4 ≥ 1.3 and <2.67 in individual groups
Time frame: through study completion, an average of 1 year
Incidence rate of liver cirrhosis in individual groups
Time frame: through study completion, an average of 1 year
The hepatology clinic referral rate of patients with FIB-4 <1.3 in individual groups
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 37549979Zhang X, Yip TC, Wong GL, Leow WX, Liang LY, Lim LL, Li G, Ibrahim L, Lin H, Lai JCT, Chim AM, Chan HLY, Kong AP, Chan WK, Wong VW. Clinical care pathway to detect advanced liver disease in patients with type 2 diabetes through automated fibrosis score calculation and electronic reminder messages: a randomised controlled trial. Gut. 2023 Nov 24;72(12):2364-2371. doi: 10.1136/gutjnl-2023-330269.
- Background: PubMed 34895743Lazarus JV, Mark HE, Villota-Rivas M, Palayew A, Carrieri P, Colombo M, Ekstedt M, Esmat G, George J, Marchesini G, Novak K, Ocama P, Ratziu V, Razavi H, Romero-Gomez M, Silva M, Spearman CW, Tacke F, Tsochatzis EA, Yilmaz Y, Younossi ZM, Wong VW, Zelber-Sagi S, Cortez-Pinto H, Anstee QM; NAFLD policy review collaborators. The global NAFLD policy review and preparedness index: Are countries ready to address this silent public health challenge? J Hepatol. 2022 Apr;76(4):771-780. doi: 10.1016/j.jhep.2021.10.025. Epub 2021 Dec 9.
- Background: PubMed 34229038Younossi ZM, Ong JP, Takahashi H, Yilmaz Y, Eguc Hi Y, El Kassas M, Buti M, Diago M, Zheng MH, Fan JG, Yu ML, Wai-Sun Wong V, Alswat K, Chan WK, Mendez-Sanchez N, Burra P, Bugianesi E, Duseja AK, George J, Papatheodoridis GV, Saeed H, Castera L, Arrese M, Kugelmas M, Romero-Gomez M, Alqahtani S, Ziayee M, Lam B, Younossi I, Racila A, Henry L, Stepanova M; Global Nonalcoholic Steatohepatitis Council. A Global Survey of Physicians Knowledge About Nonalcoholic Fatty Liver Disease. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1456-e1468. doi: 10.1016/j.cgh.2021.06.048. Epub 2021 Jul 3.
- Background: PubMed 33355256Lomonaco R, Godinez Leiva E, Bril F, Shrestha S, Mansour L, Budd J, Portillo Romero J, Schmidt S, Chang KL, Samraj G, Malaty J, Huber K, Bedossa P, Kalavalapalli S, Marte J, Barb D, Poulton D, Fanous N, Cusi K. Advanced Liver Fibrosis Is Common in Patients With Type 2 Diabetes Followed in the Outpatient Setting: The Need for Systematic Screening. Diabetes Care. 2021 Feb;44(2):399-406. doi: 10.2337/dc20-1997. Epub 2020 Dec 21.
- Background: PubMed 30551263Lai LL, Wan Yusoff WNI, Vethakkan SR, Nik Mustapha NR, Mahadeva S, Chan WK. Screening for non-alcoholic fatty liver disease in patients with type 2 diabetes mellitus using transient elastography. J Gastroenterol Hepatol. 2019 Aug;34(8):1396-1403. doi: 10.1111/jgh.14577. Epub 2019 Jan 21.
- Background: PubMed 25873639Kwok R, Choi KC, Wong GL, Zhang Y, Chan HL, Luk AO, Shu SS, Chan AW, Yeung MW, Chan JC, Kong AP, Wong VW. Screening diabetic patients for non-alcoholic fatty liver disease with controlled attenuation parameter and liver stiffness measurements: a prospective cohort study. Gut. 2016 Aug;65(8):1359-68. doi: 10.1136/gutjnl-2015-309265. Epub 2015 Apr 14.
- Background: PubMed 38078591American Diabetes Association Professional Practice Committee. 4. Comprehensive Medical Evaluation and Assessment of Comorbidities: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S52-S76. doi: 10.2337/dc24-S004.
- Background: PubMed 35842345Long MT, Noureddin M, Lim JK. AGA Clinical Practice Update: Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Lean Individuals: Expert Review. Gastroenterology. 2022 Sep;163(3):764-774.e1. doi: 10.1053/j.gastro.2022.06.023. Epub 2022 Jul 14.
- Background: PubMed 36631005Castera L, Cusi K. Diabetes and cirrhosis: Current concepts on diagnosis and management. Hepatology. 2023 Jun 1;77(6):2128-2146. doi: 10.1097/HEP.0000000000000263. Epub 2023 Jan 13.
- Background: PubMed 37542503Wattacheril JJ, Abdelmalek MF, Lim JK, Sanyal AJ. AGA Clinical Practice Update on the Role of Noninvasive Biomarkers in the Evaluation and Management of Nonalcoholic Fatty Liver Disease: Expert Review. Gastroenterology. 2023 Oct;165(4):1080-1088. doi: 10.1053/j.gastro.2023.06.013. Epub 2023 Aug 4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. To protect the patients' privacy information.
Related trials for Type 2 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
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.
Tung Hung Su, MD, PhD principal investigator
Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APP calculation for FIB-4 in people with Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 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: opening soon, as of the sponsor's last update on 22 Nov 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tung Hung Su, MD, PhD (886-972651694, tunghungsu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The hepatology clinic referral rate if FIB-4 ≥ 2.67 (advanced fibrosis, F3) (time frame: through study completion, an average of 1 year). 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 NCT06694974, which also lists 10 linked publications.
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 22 Nov 2024.