Follow-up of NAFLD Patients With MRI-PDFF

Phase 4

Completed

• Conditions: NAFLD; Diabetes Type 2
• Interventions: Drug: Empagliflozin 25 MG; Drug: Pentoxifylline 400 MG; Other: placebo; Drug: Ursodeoxycholic acid

• Registration Number: NCT04910178
• Lead Sponsor: Asmaa Abdelfattah Elsayed

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

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

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-02
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-17
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empa group	Empagliflozin 25 MG	patients will be given Empagliflozin 25 mg once daily
PTX group	Pentoxifylline 400 MG	patients will be given PTX 400 mg twice daily or 3 times daily
Placebo	placebo	patients will be given a placebo
UDCA group	Ursodeoxycholic acid	patients will be given UDCA 500 mg twice daily

Primary Outcome Measures

Name	Time	Method
liver fat content (percent)	6-months	measured by MRI-PDFF
fatty liver staging (0, I, II, and III)	6-months	using ultrasound

Secondary Outcome Measures

Name	Time	Method
Changes in Serum Gamma glutamyl transferase (γ-GT)	6-months	IU/l
HbA1c (%)	6-months
Fasting and 2-hr post-prandial serum glucose (mg/dl)	6-months
Lipid profile	6-months	(serum triglycerides, total cholesterol, LDL, HDL) (mg/dl)
Changes in liver enzymes	6-months	AST (IU/l) and ALT (IU/l)
Changes in direct and total bilirubin	6-months	(mg/dl)
Changes in total protein and albumin	6-months	(g/l)

Trial Locations

Locations (1)

Minya University Hospital; 🇪🇬 Minya, Egypt