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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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2020-12-01
2021-12-30
Brief Summary
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Detailed Description
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* 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, Empagliflozin as an example of SGLT-2 inhibitors and UDCA efficacy and safety as add-on therapy in type 2 diabetic patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Empa group
patients will be given Empagliflozin 25 mg once daily
Empagliflozin 25 MG
tablets to be taken orally once a day
PTX group
patients will be given PTX 400 mg twice daily or 3 times daily
Pentoxifylline 400 MG
tablets to be taken orally twice a day
UDCA group
patients will be given UDCA 500 mg twice daily
Ursodeoxycholic acid
tablets to be taken orally twice a day
Placebo
patients will be given a placebo
placebo
just starch tablets without any active agents
Interventions
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Empagliflozin 25 MG
tablets to be taken orally once a day
Ursodeoxycholic acid
tablets to be taken orally twice a day
Pentoxifylline 400 MG
tablets to be taken orally twice a day
placebo
just starch tablets without any active agents
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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:
1. History of recurrent attacks of UTI or Genital infection in females
2. History of recurrent foot injuries or infections
3. Type 2 diabetic patient with CV disease especially NYHA classes III/ IV
4. Immunocompromised patients or with a history of inflammatory, immunological, or malignant diseases.
* Any contraindication for PTX including:
1. Hypersensitivity to PTX
2. Patients with peptic ulcer disease or tendency for bleeding
* Any contraindication for UDCA including:
1. Hypersensitivity to UDCA
2. Patients with biliary disease or hepatobiliary disease (ascites, jaundice)
3. Patients with hepatic encephalopathy or gallstone pancreatitis
18 Years
ALL
No
Sponsors
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Asmaa Abdelfattah Elsayed
OTHER
Responsible Party
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Asmaa Abdelfattah Elsayed
PHD candidate in clinical pharmacy department and PI
Principal Investigators
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Asmaa A Elsayed, PhD
Role: PRINCIPAL_INVESTIGATOR
BUC
Locations
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Minya University Hospital
Minya, , Egypt
Countries
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Other Identifiers
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BeniSuef
Identifier Type: -
Identifier Source: org_study_id