Follow-up of NAFLD Patients With MRI-PDFF

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04910178
• Other study ID #: BeniSuef
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2022
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2
• NAFLD

Intervention

Drug:
• 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

Other:
• placebo
just starch tablets without any active agents

Locations

Country	Name	City	State
Egypt	Minya University Hospital	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Asmaa Abdelfattah Elsayed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver fat content (percent)	measured by MRI-PDFF	6-months
Primary	fatty liver staging (0, I, II, and III)	using ultrasound	6-months
Secondary	Changes in Serum Gamma glutamyl transferase (?-GT)	IU/l	6-months
Secondary	HbA1c (%)		6-months
Secondary	Fasting and 2-hr post-prandial serum glucose (mg/dl)		6-months
Secondary	Lipid profile	(serum triglycerides, total cholesterol, LDL, HDL) (mg/dl)	6-months
Secondary	Changes in liver enzymes	AST (IU/l) and ALT (IU/l)	6-months
Secondary	Changes in direct and total bilirubin	(mg/dl)	6-months
Secondary	Changes in total protein and albumin	(g/l)	6-months