Clinical trial NCT04910178: Follow-up of NAFLD Patients With MRI-PDFF
Official title: Evaluating the Effect of Pentoxifylline, Ursodiol, and Empagliflozin on Fatty Liver of Patients With Type-2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Type 2
NAFLD
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: liver fat content (percent)
timeFrame: 6-months
measure: fatty liver staging (0, I, II, and III)
timeFrame: 6-months
Secondary outcomes:
measure: Changes in Serum Gamma glutamyl transferase (γ-GT)
timeFrame: 6-months
measure: HbA1c (%)
timeFrame: 6-months
measure: Fasting and 2-hr post-prandial serum glucose (mg/dl)
timeFrame: 6-months
measure: Lipid profile
timeFrame: 6-months
measure: Changes in liver enzymes
timeFrame: 6-months
measure: Changes in direct and total bilirubin
timeFrame: 6-months
measure: Changes in total protein and albumin
timeFrame: 6-months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minya University Hospital
Study officials:
affiliation: BUC
name: Asmaa A Elsayed, PhD
role: PRINCIPAL_INVESTIGATOR
References: