Impact of Dapagliflozin in comparison with Saroglitazar on FIB-4 Score in Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Type 2 Diabetes Mellitus: A Open-Label, Randomized controlled Study
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- •To assess the efficacy of Dapagliflozin in comparison with Saroglitazar.
概览
简要总结
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Patients will be recruited from the hospital using the inclusion and exclusion criteria.
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Patients meeting the inclusion criteria and giving voluntary consent will be included in the study.
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Patients will randomly (Simple randomization) be allocated to either of the groups Dapagliflozin 10 mg once daily (Moming: after food) (Test group) or Saroglitazar 4 mg once daily (Morning; after food) (Control group).
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The following laboratory parameters will be measured at baseline (Visit 0) and after l2 weeks (Visit l): - a. Anthropometric measurements: Height (cm), weight (kg), BMI (kg/m2), waist circumference (cm)
b. Blood glucose
c. Liver function test
d. Lipid profile
e. Platelets count
f. Fibroscan- Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) 5. Using those values, Fibrosis-4 (FIB-4) index and FLI (Fatty liver index) will be calculated at baseline and at follow-up.
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Quality of life will be assessed using a validated questionnaire CLDQ NAFLD (Chronic Liver Discase Questionnaire - Non-Alcoholic Fatty Liver Discase version) at baseline and at follow-up.
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The compliance to medications will be measured by call or by face-to-face interview during the follow up.
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If any adverse events are identified during the study, it will be reported.
研究设计
- 研究类型
- Pms
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing participants with
- •Age greater than 18 years
- •Newly diagnosed or previously diagnosed with type 2 diabetes mellitus (According to American Diabetes Association, HbA1c greater than 6.5 percentage, FBS greater than 126 mg/dl, PPBS greater than 200 mg/dl)
- •Evidence of fatty liver on ultrasound
- •BMI greater than or equal to 25 kg/m2 or waist circumference greater than 94 cm in men and greater than 80 cm in women
- •No history of alcohol consumption.
排除标准
- •Chronic hepatitis B or C
- •Individuals having type- 1 diabetes mellitus or individuals on insulin therapy
- •Drugs affecting MASLD such as vitamin E, pioglitazone, SGLT2 inhibitors, Saroglitazar and glucagon-like peptide 1 analogues
- •Patients on pharmacological or non-pharmacological treatment for weight loss and patients on intentional weight losing program
- •Liver diseases due to other etiologies like autoimmune liver disease, Wilsons’ disease etc., uncontrolled thyroid disease, active cardio-pulmonary disease or chronic kidney disease
- •Cirrhotic patients
- •Lactating and pregnant women
- •Patients who were known to have cardiac and renal disorders after medical history interview
- •History of mental illness or inability to cooperate with the study.
结局指标
主要结局
•To assess the efficacy of Dapagliflozin in comparison with Saroglitazar.
时间窗: Baseline and at 12th week
•Reduction in FIB- 4 score.
时间窗: Baseline and at 12th week
次要结局
- Adherence/compliance to the medications with follow-up every month(Baseline & at 12th week)
- Improved Fatty liver index (FLI) score.(Baseline & at 12th week)
- Reduction Controlled Attenuation Parameter (CAP) & Liver Stiffness Measurement (LSM).(Baseline & at 12th week)
- Improvement in the metabolic parameters mentioned as follows: -(1. Anthropometric measurements- Height (cm), weight (kg), BMI (kg/m2), waist circumference (cm).)
- Improved health related quality of life of patients measured by the validated CLDQ-NAFLD questionnaires(Baseline & at 12th week)
- Documenting the frequency of adverse events occurring during the study period(Baseline & at 12th week)
研究者
Dr J S Kumar
SRM Institute of Science and Technology