BridgeMD
New treatment option for MAFLD
Official title A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software in Patients With MAFLD
ClinicalTrials.gov ID: NCT07233486
What this study is testing
- What it's testing
- Cirrhosis associated with metabolic associated fatty liver disease (MAFLD) can lead to a series of adverse outcomes in and outside the liver, but there is no approved treatment so far. In recent years, the prevalence of MAFLD-related cirrhosis in our country is increasing rapidly, but its clinical, pathological characteristics and natural prognosis are not clear, and there is a lack of standardized and effective prevention and treatment strategies.Through"Digital Intelligence software" to assist clinicians in MAFLD patients with remote data intervention, lifestyle intervention guidance and follow-up management, to evaluate the efficacy and safety of the intervention software on body weight and blood glucose in patients with MAFLD.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adult patients aged 18-65 years with a BMI of 24-35 kg/m².
- Confirmed diagnosis of Metabolic-associated Fatty Liver Disease (MAFLD), defined by a FibroScan® result \> 248 dB/m or an MRI-PDFF \> 5%.
- Willing and able to provide written informed consent and comply with the study protocol, including the use of a compatible smartphone for digital...
- If treated for Type 2 Diabetes Mellitus (T2DM), must be on a stable medication regimen for at least 3 months prior to baseline (Day 0), with the...
- If taking medications with potential NASH-remitting effects (e.g., vitamin E, thiazolidinediones), must be on a stable dose for at least 3 months...
You likely can't join if
- people were excluded from participation if they met any of the following criteria, based on the most recent pre-randomization assessments:
- Evidence of cirrhosis, defined as histological stage F4 or its clinical equivalent.
- History of heavy alcohol consumption (\>30 g/day for males, \>20 g/day for females) for more than 3 consecutive months within one year prior to...
- Prior or planned solid organ transplantation (excluding corneal transplants).
- Planned bariatric surgery. A history of bariatric surgery was permitted only if weight had been stable (variation \<10%) for at least 3 months prior...
- Presence of other chronic liver diseases, including:
See the full eligibility criteria
Who can join
- Adult patients aged 18-65 years with a BMI of 24-35 kg/m².
- Confirmed diagnosis of Metabolic-associated Fatty Liver Disease (MAFLD), defined by a FibroScan® result \> 248 dB/m or an MRI-PDFF \> 5%.
- Willing and able to provide written informed consent and comply with the study protocol, including the use of a compatible smartphone for digital health components.
- If treated for Type 2 Diabetes Mellitus (T2DM), must be on a stable medication regimen for at least 3 months prior to baseline (Day 0), with the expectation to maintain stability throughout the study barring medical...
- If taking medications with potential NASH-remitting effects (e.g., vitamin E, thiazolidinediones), must be on a stable dose for at least 3 months prior to Day 0.
What rules you out
- people were excluded from participation if they met any of the following criteria, based on the most recent pre-randomization assessments:
- Evidence of cirrhosis, defined as histological stage F4 or its clinical equivalent.
- History of heavy alcohol consumption (\>30 g/day for males, \>20 g/day for females) for more than 3 consecutive months within one year prior to screening.
- Prior or planned solid organ transplantation (excluding corneal transplants).
- Planned bariatric surgery. A history of bariatric surgery was permitted only if weight had been stable (variation \<10%) for at least 3 months prior to screening.
- Presence of other chronic liver diseases, including:
- Hepatitis B surface antigen (HBsAg) positivity.
- Hepatitis C virus (HCV) RNA positivity.
- Primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, or overlap syndromes.
- Wilson's disease, alpha-1 antitrypsin deficiency (ZZ phenotype), or hereditary hemochromatosis.
- History of Type 1 Diabetes Mellitus. Uncontrolled Type 2 Diabetes Mellitus, defined as HbA1c \>9% or current insulin therapy.
- History of hepatic decompensation events (e.g., ascites, hepatic encephalopathy, variceal hemorrhage).
- Any of the following laboratory abnormalities at screening:
- Platelet count \< 150,000/mm³
- Albumin \< 3.0 g/dL
- International Normalized Ratio (INR) \> 1.3
- Alkaline Phosphatase (ALP) \> 2 × Upper Limit of Normal (ULN)
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 5 × ULN
- Total Bilirubin \> 1.3 × ULN (except in cases of documented Gilbert's syndrome)
- Estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73 m²
- Hemoglobin \< 10 g/dL
- Uncontrolled thyroid dysfunction, defined as a thyroid-stimulating hormone (TSH) level \ 10 µIU/mL at screening.
- Documented HIV-1 or HIV-2 infection.
- Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
- Significant cardiovascular history, including myocardial infarction, unstable angina, heart failure, uncontrolled arrhythmia, coronary artery bypass graft, or percutaneous coronary intervention within one year prior to...
- Diagnosis of malignancy within the past 2 years (except for adequately treated basal cell carcinoma or cutaneous squamous cell carcinoma).
- Severe co-morbid respiratory, cardiac, cerebrovascular, hepatic, or renal conditions that, in the investigator's judgment, would preclude safe participation in a diet and exercise intervention.
- Active, severe infection requiring parenteral antimicrobial therapy within 30 days of screening.
- Major surgery within 30 days prior to screening.
- Chronic use of medications known to promote hepatic steatosis (e.g., systemic corticosteroids, amiodarone, methotrexate, tamoxifen, valproic acid) within 3 months of screening. Short-term, low-dose corticosteroid use...
- Current or planned treatment with radiation therapy, cytotoxic chemotherapy, or immunomodulatory agents (e.g., interleukins, interferons).
- Treatment with any investigational agent within 6 months prior to screening, or prior participation in a clinical trial for NASH/MAFLD within 6 months. Pregnancy or lactation. 1.Any other condition or circumstance that...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.