Skip to main content
OpenTrials
Completed

NCT Number: NCT04910178

Follow-up of NAFLD Patients With MRI-PDFF

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Minya University Hospital

Minya, 61118, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Empagliflozin 25 MG

Drug

tablets to be taken orally once a day

Other names: Jardiance 25mg tablets

Ursodeoxycholic acid

Drug

tablets to be taken orally twice a day

Other names: Ursofalk tablets

Pentoxifylline 400 MG

Drug

tablets to be taken orally twice a day

Other names: Trental tablets

Placebo

Other

just starch tablets without any active agents

Primary outcomes

  1. liver fat content (percent)

    Time frame: 6-months

    measured by MRI-PDFF

  2. fatty liver staging (0, I, II, and III)

    Time frame: 6-months

    using ultrasound

Secondary outcomes

  1. Changes in Serum Gamma glutamyl transferase (γ-GT)

    Time frame: 6-months

    IU/l

  2. HbA1c (%)

    Time frame: 6-months

  3. Fasting and 2-hr post-prandial serum glucose (mg/dl)

    Time frame: 6-months

  4. Lipid profile

    Time frame: 6-months

    (serum triglycerides, total cholesterol, LDL, HDL) (mg/dl)

  5. Changes in liver enzymes

    Time frame: 6-months

    AST (IU/l) and ALT (IU/l)

  6. Changes in direct and total bilirubin

    Time frame: 6-months

    (mg/dl)

  7. Changes in total protein and albumin

    Time frame: 6-months

    (g/l)

Sponsors and collaborators

Lead sponsor

Asmaa Abdelfattah Elsayed

Other

Registry information

Official study title

Evaluating the Effect of Pentoxifylline, Ursodiol, and Empagliflozin on Fatty Liver of Patients With Type-2 Diabetes

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2021
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.