Follow-up of NAFLD Patients With MRI-PDFF

Asmaa Abdelfattah Elsayed

Status and phase: Completed; Phase 4

Conditions: NAFLD; Diabetes Type 2

Treatments: Other: placebo; Drug: Empagliflozin 25 MG; Drug: Pentoxifylline 400 MG; Drug: Ursodeoxycholic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04910178

BeniSuef

Details and patient eligibility

About

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 are proposed to play an important role in the pathogenesis of both NAFLD and T2DM.

Full 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, Empagliflozin as an example of SGLT-2 inhibitors and UDCA efficacy and safety as add-on therapy in type 2 diabetic patients.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• • 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:

    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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups, including a placebo group

Empa group

Experimental group

Description:

patients will be given Empagliflozin 25 mg once daily

Treatment:

Drug: Empagliflozin 25 MG

PTX group

Experimental group

Description:

patients will be given PTX 400 mg twice daily or 3 times daily

Treatment:

Drug: Pentoxifylline 400 MG

UDCA group

Experimental group

Description:

patients will be given UDCA 500 mg twice daily

Treatment:

Drug: Ursodeoxycholic acid

Placebo

Placebo Comparator group

Description:

patients will be given a placebo

Treatment:

Other: placebo