Intervention of Henagliflozin on Liver Fibrosis in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) and Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Liver stiffness measurements (LSM) of subjects
研究概览
简要总结
The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) is increasing due to changes in economic conditions and lifestyle, and it is anticipated to become a significant liver disease burden in the future. This is particularly true for patients with MASLD who also have type 2 diabetes mellitus (T2DM), as the rate of comorbidity between these conditions has risen in recent years due to their shared mechanisms, necessitating careful management of both. Liver fibrosis is a critical concern, as poor blood glucose control can worsen liver fibrosis, which in turn complicates blood sugar management. Therefore, addressing liver fibrosis in patients with MASLD and T2DM is urgent, yet there are currently no targeted therapies to reverse its progression. SGLT2 inhibitors, have shown promise in potentially reversing liver fibrosis, but existing research is limited and has not adequately focused on liver fibrosis improvement, highlighting the need for more robust evidence-based studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
In the process of randomizing groups, the study designers assigned a blinded code to each participant. This coding is organized based on the order of enrollment.Only the study implementer will have access to the serial numbers of the study subjects, the blinded codes, and the drugs labeled with those codes. The details of the blind codes are known solely to the lead study designers and are maintained by designated personnel. At this stage, as the study implementer includes participants in sequence, only the drugs labeled with the corresponding codes can be administered, ensuring that neither the implementer nor the participants are aware of the group assignments or the drugs being used.To assess the quality of blinding completion, we employed the James Blinding Index (JBI) and the Bang Blinding Index (BBI) as evaluative tools.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be aged between 18 and 75 years.
- •Participants must meet the diagnostic criteria for MASLD and T2DM.
- •Participants' HbA1c level between 6.5% and 9%.
- •The LSM obtained via the FibroScan device must be equal to or greater than 8 kPa.
- •Participants must not have experienced a significant change in body weight exceeding 15% within the past four weeks.
- •Participants must not have utilized non-biguanide hypoglycemic medications in the three months preceding the study.
排除标准
- •Patients diagnosed with non-MASLD, which encompasses conditions such as viral hepatitis, autoimmune liver disease, liver tumors, and drug-induced liver injury, among others;
- •Individuals exhibiting ALT and/or AST levels that exceed the normal range by threefold or more;
- •Patients currently using or having used medications associated with secondary MASLD (including, but not limited to, corticosteroids, estrogen, amiodarone, methotrexate, etc.) within the preceding three months;
- •Individuals utilizing or having utilized medications within the last three months that possess the potential to ameliorate hepatic steatosis or fibrosis in MASLD (including, but not limited to, ursodeoxycholic acid, bicyclol tablets, silymarin capsules, polyene phosphatidylcholine capsules, vitamin E, etc.);
- •Patients with known or suspected elevated alcohol consumption (females exceeding 12 grams per day; males exceeding 24 grams per day) or those on medications that may contribute to increased consumption;
- •Individuals who have experienced severe acute complications such as hypoglycemia, ketoacidosis, hyperglycemia, or hyperosmolar states within the past month or during the course of medication;
- •Patients who have undergone metabolic bariatric surgery or are currently participating in bariatric treatment;
- •Individuals with significant primary systemic pathologies, including but not limited to respiratory, circulatory, digestive, urinary, neurological, hematological, rheumatological, endocrine diseases, tumors, or AIDS;
- •Female participants who are pregnant, breastfeeding, or of childbearing potential and not employing a highly effective contraceptive method;
- •Individuals with known allergies or potential allergies to the medications utilized in this study, rendering them intolerant;
- •Patients with a history of recurrent or severe urinary and genital tract infections;
- •Individuals exhibiting severe cognitive impairment or mental illness that impedes their ability to cooperate;
- •Patients currently engaged in clinical observation of other pharmacological agents.
研究组 & 干预措施
Control Group
Placebo + Metformin 1.7g/d
干预措施: Metformin 1700 mg daily (Drug)
Control Group
Placebo + Metformin 1.7g/d
干预措施: Placebo of Henagliflozin (Other)
Intervention Group
Henagliflozin 10mg/d + Metformin 1.7g/d
干预措施: Henagliflozin 10 mg daily (Drug)
Intervention Group
Henagliflozin 10mg/d + Metformin 1.7g/d
干预措施: Metformin 1700 mg daily (Drug)
结局指标
主要结局
Liver stiffness measurements (LSM) of subjects
时间窗: From enrollment to the treatment at 24 and 48 weeks
As determined by magnetic resonance elastography (MRE)
次要结局
- Efficacy Evaluation of MASLD in fibrosis(From enrollment to the treatment at 24 and 48 weeks)
- Efficacy Evaluation of MASLD in liver fatty quantification(From enrollment to the treatment at 24 and 48 weeks)
- Efficacy Evaluation of MASLD in non-invasive biological indicators related to liver fibrosis(From enrollment to the treatment at 24 and 48 weeks)
- Renal function(From enrollment to the treatment at 24 and 48 weeks)
- Liver function(From enrollment to the treatment at 24 and 48 weeks)
- Lipid metabolism(From enrollment to the treatment at 24 and 48 weeks)
- Efficacy Evaluation of T2DM(From enrollment to the treatment at 24 and 48 weeks)
研究者
Xiqiao Zhou
Professor
Jiangsu Province Hospital of Traditional Chinese Medicine