Follow-up of NAFLD Patients With MRI-PDFF

December 17, 2022 updated by: Asmaa Abdelfattah Elsayed

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61118
        • Minya university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Empa group
patients will be given Empagliflozin 25 mg once daily
Drug: Empagliflozin 25 MG
tablets to be taken orally once a day
Other Names:
  • Jardiance 25mg tablets
Experimental: PTX group
patients will be given PTX 400 mg twice daily or 3 times daily
Drug: Pentoxifylline 400 MG
tablets to be taken orally twice a day
Other Names:
  • Trental tablets
Experimental: UDCA group
patients will be given UDCA 500 mg twice daily
Drug: Ursodeoxycholic acid
tablets to be taken orally twice a day
Other Names:
  • Ursofalk tablets
Placebo Comparator: Placebo
patients will be given a placebo
Other: placebo
just starch tablets without any active agents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
liver fat content (percent)
Time Frame: 6-months
measured by MRI-PDFF
6-months
fatty liver staging (0, I, II, and III)
Time Frame: 6-months
using ultrasound
6-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Serum Gamma glutamyl transferase (γ-GT)
Time Frame: 6-months
IU/l
6-months
HbA1c (%)
Time Frame: 6-months
6-months
Fasting and 2-hr post-prandial serum glucose (mg/dl)
Time Frame: 6-months
6-months
Lipid profile
Time Frame: 6-months
(serum triglycerides, total cholesterol, LDL, HDL) (mg/dl)
6-months
Changes in liver enzymes
Time Frame: 6-months
AST (IU/l) and ALT (IU/l)
6-months
Changes in direct and total bilirubin
Time Frame: 6-months
(mg/dl)
6-months
Changes in total protein and albumin
Time Frame: 6-months
(g/l)
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asmaa Abdelfattah Elsayed

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Asmaa A Elsayed, PhD, BUC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BeniSuef

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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