PEARL-DM: Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD; Randomized Controlled Trial From Pakistan.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- A change in liver steatosis will be assessed through fibro CAP score.
研究概览
简要总结
This clinical trial will yield results about the therapeutic effect of combining pioglitazone with SGLT2i in people suffering from NAFLD associated with T2DM. Study participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to their health. In addition, some blood tests will be done following standard procedures.
详细描述
This is a randomized clinical trial conducted to compare the efficacies of pioglitazone and empagliflozin in people suffering from NAFLD associated with T2DM.
Randomization will be done using card randomization. Four different color-coded cards will be kept. Any card will be randomly picked for the patient fulfilling inclusion criteria and will be treated according to the allocated treatment arm mentioned on the card
Written informed consent will be obtained from the immediate attendant of the patient. All ethical considerations will be followed.
Our research has been approved by Jinnah Sindh Medical University, Karachi. For this approval, the investigators have made every effort to ensure the confidentiality of research data collected from all our participants in this survey. The information collected will be stored with the investigators only in the form of de-identified information and will be retained in a secure place under lock and key. Any results that will be generated will be presented on a collective basis, and will not contain the participants name or any other personal details.
Data entry and analysis will be done using SPSS Software version 23. Study analysis will be done using the principle of intention to treat. The mean scores will be compared pre and post-intervention using paired t-test. The association of age, gender, and grade of fatty liver will be compared with different groups using correlation and regression models. All analyses will be at a confidence Interval of 95% and a p-value <.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM patients with NAFLD glycated
- •APRI scores of more than 1.5
排除标准
- •Patients having type 1 diabetes
- •evidence of advanced/decompensated cirrhosis (on the basis of a Child-Pugh score of more than 7 and MELD of more than 15)
- •hepatocellular carcinoma (evidence on ultrasound or alpha-fetoprotein)
- •patient suffering from acute or chronic hepatitis
- •biliary disease
- •hemochromatosis
- •autoimmune conditions (alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease)
- •renal dysfunction with GFR [eGFR] <30 mL/min/1.73m2
- •history of alcohol ( male >30 g/d and female;20 g/d)
- •history of cancer or undergoing treatment for cancer,
- •use of amiodarone, tamoxifen, sodium valproate, corticosteroids, methotrexate, ursodeoxycholic acid, S-adenosyl methionine, betaine, silymarin, gemfibrozil
- •using supplements including vitamin E, vitamin C, zinc, and selenium or antioxidant agents over the last 3 months
- •history of cardiovascular events within the past 3 months
- •pregnancy or breastfeeding
- •contraindications to empagliflozin use (history of recurrent urogenital infections, current or previous gangrene, or hypersensitivity reaction to the molecule)
- •history of bladder cancer
- •morbid obesity (BMI greater than 35).
研究组 & 干预措施
Group C
SOC+ Pioglitazone
干预措施: Pioglitazone 15mg (Drug)
Group A
SOC+ Empagliflozin + Pioglitazone
干预措施: Empagliflozin 10 MG (Drug)
Group A
SOC+ Empagliflozin + Pioglitazone
干预措施: Pioglitazone 15mg (Drug)
Group A
SOC+ Empagliflozin + Pioglitazone
干预措施: Metformin (Drug)
Group B
SOC +Empagliflozin
干预措施: Empagliflozin 10 MG (Drug)
Group B
SOC +Empagliflozin
干预措施: Metformin (Drug)
Group C
SOC+ Pioglitazone
干预措施: Metformin (Drug)
Group D
SOC only
干预措施: Metformin (Drug)
结局指标
主要结局
A change in liver steatosis will be assessed through fibro CAP score.
时间窗: Will be assessed at 168th day post enrollment.
Fibro-controlled attenuation parameter (fibro CAP). The parameter range is commonly between 100 and 400 dB/m, and the greater the reading worse will be the outcome.
次要结局
- change in liver fibrosis will be assessed through the NFS Score.(at day 252 post enrollment.)
- Change in hepatic steatosis through the FLI score.(at day 252 post enrollment.)
- Change in waist circumference(at day 252 post enrollment.)
- Change in HbA1c(at day 252 post enrollment.)
- Change in Body mass index(at enrollment.)
- Change in body mass index(at day 252 post enrollment.)
- change in SF-36 scores(Quality of life will be assessed at day 252 post enrollment.)
- change in liver fibrosis will be assessed through the FIB-4 index.(at day 252 post enrollment.)
- change in liver fibrosis will be assessed through the APRI Score(at 168th day post enrollment.)
- Change in the LFT.(at day 252 post enrollment.)
- Change in random blood sugar(at day 252 post enrollment.)
- change in liver fibrosis will be assessed through the APRI Score.(at day 252 post enrollment.)
- Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.(at day 252 post enrollment.)
- Change in weight(at day 252 post enrollment.)
研究者
ZA
Associate professor
Jinnah Postgraduate Medical Centre