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Follow-up of NAFLD Patients With MRI-PDFF

Primary Purpose

Diabetes Type 2, NAFLD

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Empagliflozin 25 MG

Ursodeoxycholic acid

Pentoxifylline 400 MG

placebo

About this trial

This is an interventional treatment trial for Diabetes Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Minya University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Empa group

PTX group

UDCA group

Placebo

Arm Description

patients will be given Empagliflozin 25 mg once daily

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

patients will be given UDCA 500 mg twice daily

patients will be given a placebo

Outcomes

Primary Outcome Measures

liver fat content (percent)

measured by MRI-PDFF

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

using ultrasound

Secondary Outcome Measures

Changes in Serum Gamma glutamyl transferase (γ-GT)

IU/l

HbA1c (%)

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

Lipid profile

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

Changes in liver enzymes

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

Changes in direct and total bilirubin

(mg/dl)

Changes in total protein and albumin

(g/l)

Full Information

NCT ID

NCT04910178

First Posted

May 25, 2021

Last Updated

December 17, 2022

Sponsor

Asmaa Abdelfattah Elsayed

1. Study Identification

Unique Protocol Identification Number

NCT04910178

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Asmaa Abdelfattah Elsayed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Type 2, NAFLD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Empa group

Arm Type

Experimental

Arm Description

patients will be given Empagliflozin 25 mg once daily

Arm Title

PTX group

Arm Type

Experimental

Arm Description

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

Arm Title

UDCA group

Arm Type

Experimental

Arm Description

patients will be given UDCA 500 mg twice daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

patients will be given a placebo

Intervention Type

Drug

Intervention Name(s)

Empagliflozin 25 MG

Other Intervention Name(s)

Jardiance 25mg tablets

Intervention Description

tablets to be taken orally once a day

Intervention Type

Drug

Intervention Name(s)

Ursodeoxycholic acid

Other Intervention Name(s)

Ursofalk tablets

Intervention Description

tablets to be taken orally twice a day

Intervention Type

Drug

Intervention Name(s)

Pentoxifylline 400 MG

Other Intervention Name(s)

Trental tablets

Intervention Description

tablets to be taken orally twice a day

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

just starch tablets without any active agents

Primary Outcome Measure Information:

Title

liver fat content (percent)

Description

measured by MRI-PDFF

Time Frame

6-months

Title

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

Description

using ultrasound

Time Frame

6-months

Secondary Outcome Measure Information:

Title

Changes in Serum Gamma glutamyl transferase (γ-GT)

Description

IU/l

Time Frame

6-months

Title

HbA1c (%)

Time Frame

6-months

Title

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

Time Frame

6-months

Title

Lipid profile

Description

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

Time Frame

6-months

Title

Changes in liver enzymes

Description

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

Time Frame

6-months

Title

Changes in direct and total bilirubin

Description

(mg/dl)

Time Frame

6-months

Title

Changes in total protein and albumin

Description

(g/l)

Time Frame

6-months

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Adults aged ≥ 18 years old presented at the clinic with a confirmed diagnosis of T2DM

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asmaa A Elsayed, PhD

Organizational Affiliation

BUC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Minya University Hospital

City

Minya

ZIP/Postal Code

61118

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Follow-up of NAFLD Patients With MRI-PDFF

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