Efficacy of Empagliflozin and Pioglitazone in Diabetic Patients With NAFLD
NCT ID: NCT05942963
Last Updated: 2023-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2023-10-31
2024-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Group A
SOC+ Empagliflozin + Pioglitazone
Empagliflozin 10 MG
10-25 mg/day
Pioglitazone 15mg
15-45 mg/day
Metformin
1000mg-2850mg/ day
Group B
SOC +Empagliflozin
Empagliflozin 10 MG
10-25 mg/day
Metformin
1000mg-2850mg/ day
Group C
SOC+ Pioglitazone
Pioglitazone 15mg
15-45 mg/day
Metformin
1000mg-2850mg/ day
Group D
SOC only
Metformin
1000mg-2850mg/ day
Interventions
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Empagliflozin 10 MG
10-25 mg/day
Pioglitazone 15mg
15-45 mg/day
Metformin
1000mg-2850mg/ day
Eligibility Criteria
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Inclusion Criteria
* APRI scores of more than 1.5
Exclusion Criteria
* 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
* HIV
* 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).
18 Years
ALL
No
Sponsors
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Jinnah Postgraduate Medical Centre
OTHER_GOV
Responsible Party
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ZA
Associate professor
Locations
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Medical ICU, Jinnah Postgraduate Medical Centre
Karachi, Sindh, Pakistan
Countries
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Other Identifiers
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JSMU/IRB/2023/709
Identifier Type: -
Identifier Source: org_study_id
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