Status:
COMPLETED
Follow-up of NAFLD Patients With MRI-PDFF
Lead Sponsor:
Asmaa Abdelfattah Elsayed
Conditions:
Diabetes Type 2
NAFLD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The liver is a key organ in metabolism and contributes to T2DM development and insulin resistance via unclear mechanisms that may involve liver fat accumulation, inflammatory signals, and immune cells...
Detailed Description
This study aims to define * The effects of PTX, Empagliflozin as an example of SGLT-2 inhibitors and UDCA on liver biomarkers and liver steatosis in type 2 diabetic patients. * Studying PTX, Empaglif...
Eligibility Criteria
Inclusion
- Patients who are willing to participate in this study
- Adults aged ≥ 18 years old presented at the clinic with a confirmed diagnosis of T2DM who are on sulfonylurea for the last 6 months at least and diagnosed with NAFLD.
Exclusion
- • Patients who refused to participate in this trial
- Patients diagnosed with Type 1 diabetes
- Previous history of alcohol intake
- history of recurrent attacks of ketoacidosis in a diabetic patient
- Type 2 diabetic patient with kidney dysfunction (estimated eGFR below 60ml/min/1.73m2 or CrCl below 60ml/min) or on dialysis
- Previous history of taking medication that may alter either drug efficacy (eg, corticosteroids, oral contraceptives, and thiazide diuretics)
- Evidence of another liver disease (viral hepatitis, drug-induced liver disease, autoimmune hepatitis)
- Lactating/pregnant female or children ≤ 18
- Any contraindication for Empagliflozin including:
- History of recurrent attacks of UTI or Genital infection in females
- History of recurrent foot injuries or infections
- Type 2 diabetic patient with CV disease especially NYHA classes III/ IV
- Immunocompromised patients or with a history of inflammatory, immunological, or malignant diseases.
- Any contraindication for PTX including:
- Hypersensitivity to PTX
- Patients with peptic ulcer disease or tendency for bleeding
- Any contraindication for UDCA including:
- Hypersensitivity to UDCA
- Patients with biliary disease or hepatobiliary disease (ascites, jaundice)
- Patients with hepatic encephalopathy or gallstone pancreatitis
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04910178
Start Date
December 1 2020
End Date
December 30 2021
Last Update
December 20 2022
Active Locations (1)
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1
Minya University Hospital
Minya, Egypt, 61118