Diabetes Type 2Phase 4NCT04910178
Follow-up of NAFLD Patients With MRI-PDFF
A Phase 4 study testing Empagliflozin 25 MG, Ursodeoxycholic acid and Pentoxifylline 400 MG in people with Diabetes Type 2 and NAFLD, run by Asmaa Abdelfattah Elsayed at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2, NAFLD
- What is being tested?
- Empagliflozin 25 MG, Ursodeoxycholic acid and Pentoxifylline 400 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 30 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Type 2, NAFLD
- Being tested
- Empagliflozin 25 MG, Ursodeoxycholic acid, Pentoxifylline 400 MG, placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MGDrug
Also called Jardiance 25mg tablets
tablets to be taken orally once a day
Ursodeoxycholic acidDrug
Also called Ursofalk tablets
tablets to be taken orally twice a day
Pentoxifylline 400 MGDrug
Also called Trental tablets
tablets to be taken orally twice a day
placeboOther
just starch tablets without any active agents
| Study group | Role | What they receive |
|---|---|---|
| Empa group | Experimental | patients will be given Empagliflozin 25 mg once daily Receives: Drug: Empagliflozin 25 MG |
| PTX group | Experimental | patients will be given PTX 400 mg twice daily or 3 times daily Receives: Drug: Pentoxifylline 400 MG |
| UDCA group | Experimental | patients will be given UDCA 500 mg twice daily Receives: Drug: Ursodeoxycholic acid |
| Placebo | Placebo comparator | patients will be given a placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver fat content (percent)
measured by MRI-PDFF
Measured: 6-months
fatty liver staging (0, I, II, and III)
using ultrasound
Measured: 6-months
Secondary outcomes (7)
Changes in Serum Gamma glutamyl transferase (γ-GT)
IU/l
Measured: 6-months
HbA1c (%)
Measured: 6-months
Fasting and 2-hr post-prandial serum glucose (mg/dl)
Measured: 6-months
Lipid profile
(serum triglycerides, total cholesterol, LDL, HDL) (mg/dl)
Measured: 6-months
Changes in liver enzymes
AST (IU/l) and ALT (IU/l)
Measured: 6-months
Changes in direct and total bilirubin
(mg/dl)
Measured: 6-months
Changes in total protein and albumin
(g/l)
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Dec 2020
- Primary completion1 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asmaa Abdelfattah Elsayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asmaa Abdelfattah Elsayed, Beni-Suef University
- Investigators
- Asmaa A Elsayed, PhD, Principal investigator, BUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910178
- Sponsor's protocol ID
- BeniSuef
- Status last verified
- Dec 2022
- First submitted
- 25 May 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Pentoxifylline, Ursodiol, and Empagliflozin on Fatty Liver of Patients With Type-2 Diabetes
- ClinicalTrials.gov ID
- NCT04910178
- Acronym / sponsor ID
- BeniSuef
- Conditions
- Diabetes Type 2, NAFLD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Asmaa Abdelfattah ElsayedUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Empa group | Experimental | Drug: Empagliflozin 25 MGpatients will be given Empagliflozin 25 mg once daily |
| PTX group | Experimental | Drug: Pentoxifylline 400 MGpatients will be given PTX 400 mg twice daily or 3 times daily |
| UDCA group | Experimental | Drug: Ursodeoxycholic acidpatients will be given UDCA 500 mg twice daily |
| Placebo | Placebo comparator | Other: placebopatients will be given a placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (20 listed)
- • Patients who refused to participate in this trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 25 MGAlso: Jardiance 25mg tabletstablets to be taken orally once a day | Drug | Empa group |
| Ursodeoxycholic acidAlso: Ursofalk tabletstablets to be taken orally twice a day | Drug | UDCA group |
| Pentoxifylline 400 MGAlso: Trental tabletstablets to be taken orally twice a day | Drug | PTX group |
| placebojust starch tablets without any active agents | Other | Placebo |
Primary outcome
liver fat content (percent)
Time frame: 6-months
measured by MRI-PDFF
fatty liver staging (0, I, II, and III)
Time frame: 6-months
using ultrasound
7 secondary outcomes
Changes in Serum Gamma glutamyl transferase (γ-GT)
Time frame: 6-months
HbA1c (%)
Time frame: 6-months
Fasting and 2-hr post-prandial serum glucose (mg/dl)
Time frame: 6-months
Lipid profile
Time frame: 6-months
Changes in liver enzymes
Time frame: 6-months
Changes in direct and total bilirubin
Time frame: 6-months
Changes in total protein and albumin
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa A Elsayed, PhD principal investigator
BUC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 25 MG, Ursodeoxycholic acid and Pentoxifylline 400 MG in people with Diabetes Type 2 and NAFLD, run by Asmaa Abdelfattah Elsayed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver fat content (percent) (time frame: 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.