Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000032550
Ethics application status
Approved
Date submitted
6/08/2023
Date registered
15/01/2024
Date last updated
15/01/2024
Date data sharing statement initially provided
15/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of ertugliflozin in patients with nonalcoholic fatty liver disease (NAFLD) associated with type 2 diabetes mellitus.
Scientific title
The effect of ertugliflozin on liver function in patients with nonalcoholic fatty liver disease (NAFLD) associated with type 2 diabetes mellitus.
Secondary ID [1] 310308 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Fatty liver diseases 331017 0
Elevated liver enzymes 331018 0
Obesity 331019 0
Insulin resistance 331020 0
Non alcoholic acute Steatohepatitis (NASH) 331021 0
Condition category
Condition code
Metabolic and Endocrine 327820 327820 0 0
Metabolic disorders
Metabolic and Endocrine 328265 328265 0 0
Diabetes
Oral and Gastrointestinal 328266 328266 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The total number of participants will be randomized into 3 groups. The 1:1:1 allocation sequence will be used for dug administration. The first group will take Ertugliflozin 15 mg oral tablet once daily for 6 months. The second group will take a control drug Pioglitazone oral tablet once daily for 6 months while the third group will receive a placebo (starch tablets) orally once daily for 6 months. The drug is given to patients with a regular diet. The side effects were explained in detail. The monitoring of possible side effects will be determined through information given by participants or self reporting method. The intervention will be continued for 24 weeks (6 months). The baseline of all biochemical parameter will be measured and recorded in each patient record. At 12th week (3 months) the baseline of all biomarker will be measured in order to asses any improvement in fatty liver grading, liver enzyme and quality of life. The adherence strategies involve the counting of pills returned by participant. Self-monitoring of blood sugar was done by patients to monitor blood sugar fluctuations and HbA1c was also monitored in the mid of the observation period to maintain glycemic targets. The frequency of patient visits was individualized as per the blood glucose levels. The total interventional period is 6-8 months. Other necessary investigations were done during the observation period on the required basis to prevent any complications or side effects and to monitor the rapid deterioration of liver functions. The data will be compared to the placebo as well as to the control. The difference will be measured and recorded along with all biomarkers data.
Intervention code [1] 326690 0
Treatment: Drugs
Comparator / control treatment
The control drug will be used for this is pioglitazone 30mg oral once daily for 6 months.
The negative control is Placebo (starch tablet) oral once daily for 6 months will be given to the participants.
Control group
Active

Outcomes
Primary outcome [1] 335671 0
Determination of change in Liver function Profile (LFT) through biochemical analysis.
Timepoint [1] 335671 0
At baseline (0 week), (12 week) (primary timepoint) and (24 week) post intervention commencement.
Primary outcome [2] 336128 0
Assessment of change in Lipid profile through blood test.
Timepoint [2] 336128 0
At baseline (0 week), (12 week) (primary timepoint) and (24 week) post intervention commencement.
Primary outcome [3] 336129 0
Analysis of change in blood glucose level through blood test.
Timepoint [3] 336129 0
At baseline (0 week), (12 week) (primary timepoint) and (24 week) post intervention commencement.
Secondary outcome [1] 425145 0
Ultrasonography of patient in order to determine the fatty liver grading from (0-1).
Timepoint [1] 425145 0
At baseline (0 week), 12 week and 24 week (post intervention commencement).
Secondary outcome [2] 425146 0
Identification of change in Glycated hemoglobin (HbA1C) assessed by blood test.
Timepoint [2] 425146 0
At baseline (0 week), 12 week and 24 week (post intervention commencement).
Secondary outcome [3] 426927 0
Change in Insulin Resistance HOMA-IR assessed by blood test.
Timepoint [3] 426927 0
At baseline (0 week), 12 week and 24 week (post intervention commencement).
Secondary outcome [4] 426928 0
Any change in Fibrosis-4 (FIB-4) index analyze through blood test.
Timepoint [4] 426928 0
At baseline (0 week), 12 week and 24 week (post intervention commencement).

Eligibility
Key inclusion criteria
Participants for this RCT must be Adult patients (above age of 20 years), diagnosed with non alcoholic fatty liver diseases along with type 2 diabetes mellitus.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants not having non alcoholic fatty liver diseases along with type 2 diabetes mellitus., not willing to participate and the patient having elevated liver enzyme with any other risk factor such as hepatitis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomized into three groups i.e. control, placebo and intervention group by random technique will be used form a list of random numbers obtained from computer of eligible patients which will be compiled by using the patients’ hospital identification numbers. After recruitment, the patients will be given a required packing of medication allocation to either control or intervention group or placebo with 1:1:1 randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analyzed using SPSS software version 27 (Chicago, Illinois, USA), and the results will be expressed as mean ± standard deviation. The intention-to-treat (ITT) analysis was performed on all the randomized patients who received at least one dose of the study medications. Within-group comparisons were conducted using the paired-sample t-test. Between-group comparisons were performed using one-way analysis of variance (ANOVA) and Chi-squared test for normally distributed variables. A p-value of less than 0.05 was considered statistically significant in all statistical analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 25693 0
Pakistan
State/province [1] 25693 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 314519 0
University
Name [1] 314519 0
Abdul Wali Khan University
Country [1] 314519 0
Pakistan
Primary sponsor type
University
Name
Abdul Wali Khan University
Address
Bacha Khan Monument, Nowshera Mardan Rd, Muslimabad, Mardan, Khyber Pakhtunkhwa 23200
Country
Pakistan
Secondary sponsor category [1] 316466 0
Individual
Name [1] 316466 0
ADIL KHALIQ
Address [1] 316466 0
Bacha Khan Monument, Nowshera Mardan Rd, Muslimabad, Mardan, Khyber Pakhtunkhwa 23200
Country [1] 316466 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313560 0
District Head Quarter Hospital
Ethics committee address [1] 313560 0
Ethics committee country [1] 313560 0
Pakistan
Date submitted for ethics approval [1] 313560 0
02/01/2023
Approval date [1] 313560 0
03/02/2023
Ethics approval number [1] 313560 0
DHQH/2023/04-33

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128550 0
Mr ADIL KHALIQ
Address 128550 0
Bacha Khan Monument, Nowshera Mardan Rd, Muslimabad, Mardan, Khyber Pakhtunkhwa 23200
Country 128550 0
Pakistan
Phone 128550 0
+923139668112
Fax 128550 0
Email 128550 0
[email protected]
Contact person for public queries
Name 128551 0
ADIL KHALIQ
Address 128551 0
Bacha Khan Monument, Nowshera Mardan Rd, Muslimabad, Mardan, Khyber Pakhtunkhwa 23200
Country 128551 0
Pakistan
Phone 128551 0
+923139668112
Fax 128551 0
Email 128551 0
[email protected]
Contact person for scientific queries
Name 128552 0
Haroon Badshah
Address 128552 0
Abdul Wali Khan University Mardan, Bacha Khan Monument, Nowshera Mardan Rd, Muslimabad, Mardan, Khyber Pakhtunkhwa 23200
Country 128552 0
Pakistan
Phone 128552 0
+923405840121
Fax 128552 0
Email 128552 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data of published results only.
When will data be available (start and end dates)?
Immediately after publication with no end date.
Available to whom?
Will be available to anyone who want to access.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
[email protected]
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.