Comparison of the effects of pioglitazone and Glurenta on metabolic factors in patients with non-alcoholic fatty liver disease and type 2 diabetes referred to Clinic
Design
Single-blind, non-controlled phase 4 clinical trial on 72 patients
Settings and conduct
In this single-blind trial, the researchers involved in assessing the outcomes are unaware of the type of intervention that the patients receive. The study uses an independent person to collect the data, who has no connection to the intervention, and after the data is collected, the results are analyzed.Patients are assigned to groups using random blocks after obtaining informed consent. Also, in this study, no additional testing or costs are imposed on patients in addition to the diagnostic and treatment process.72 patients with diabetes and non-alcoholic fatty liver disease were divided into two groups of 36, one group receiving pioglitazone 15 mg daily and the other group receiving 10.5 mg daily.
The dose of 10.5 mg of glorenta is an effective dose. After grouping, pioglitazone and glorenta are administered orally once a day for 6 months.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 75 years with non-alcoholic fatty liver disease and type 2 diabetes
No history of alcohol consumption (20 grams per day for women and 30 grams per day for men)
Intervention groups
72 patients with diabetes and non-alcoholic fatty liver disease were divided into two groups of 36, one group receiving pioglitazone 15 mg daily and the other group receiving 10.5 mg daily.
The dose of 10.5 mg daily is an effective dose. After grouping, pioglitazone and 10.5 mg daily are administered orally for 6 months.
Comparison of the effect of pioglitazone and Gloranta on metabolic factors of patients with non-alcoholic fatty liver disease and type 2 diabetes
Public title
Comparison of the effect of pioglitazone and Gloranta on metabolic factors of patients with non-alcoholic fatty liver disease and type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 75 years with non-alcoholic fatty liver disease and type 2 diabetes
No history of alcohol consumption (20 grams per day for women and 30 grams per day for men)
No history of cardiovascular events in the past 3 months
Not pregnant or breastfeeding; active cancer or history of cancer treatment in the past 2 years; body mass index above 40 kg/m2.
Exclusion criteria:
Active or chronic hepatitis; cirrhosis and biliary disease; heart failure, renal dysfunction (eGFR <45 ml/min/1.73 m2) during the study
Taking medications associated with fatty liver nonsteroidal anti-inflammatory drugs (NSAIDs) (amiodarone, tamoxifen, sodium valproate, corticosteroids, methotrexate).
Simultaneous use of both drugs, Glurenta and Empagliflozin
Age
From 18 years old to 75 years old
Gender
Both
Phase
4
Groups that have been masked
Data analyser
Sample size
Target sample size:
72
More than 1 sample in each individual
Number of samples in each individual:
2
Blood sample and ultrasound
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blind trial, the researchers involved in assessing the outcomes are unaware of the type of intervention that the patients receive. The study uses an independent person to collect the data who has no connection to the intervention, and after the data is collected, the results will be analyzed.
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatullah University of Medical Sciences
Street address
No. 24, Hakimian Alley, Badakhshan Kamali Street, Abuzar Street
City
Tehran
Province
Tehran
Postal code
1363935191
Approval date
2025-08-06, 1404/05/15
Ethics committee reference number
IR.BMSU.REC.1404.015
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
2
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Liver enzymes
Timepoint
Measurement of liver enzymes at the beginning of the study before the start of the intervention and 6 months after the start of Glurenta or pioglitazone
Method of measurement
A blood sample
2
Description
blood pressure
Timepoint
At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone
Method of measurement
Blood pressure measuring device
3
Description
Body mass index of individuals
Timepoint
At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone
Method of measurement
Scales and meters
4
Description
، LDL، HDL، Total cholesterol,Triglycerides
Timepoint
At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone
Method of measurement
blood sample
5
Description
Fatty liver
Timepoint
At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone
Method of measurement
The amount of liver fat is determined by ultrasound and fibroscan and based on the interpretation of the radiologist.
6
Description
(FBS، BS2hpp، Hba1c)
Timepoint
At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone
Method of measurement
blood sample
7
Description
platelet
Timepoint
At the beginning of the study before the start of the intervention and 6 months after starting Glorenta or pioglitazone
Method of measurement
blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: 72 people with diabetes and non-alcoholic fatty liver disease were divided into two groups of 36 people: one group received pioglitazone 15 mg daily and the other group received 10.5 mg daily.The dose of Glurenta is 10.5 mg. An effective dose. Glurenta is administered orally once a day for 6 months. Then a blood sample is taken. Fasting blood glucose levels after 8 hours of fasting, blood levels of alanine aminotransferase (ALT), triglycerides (TG), free fatty acids (FFA) and CBC, ultrasound and cases requiring fibroscan are measured.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: 72 patients with diabetes and non-alcoholic fatty liver disease were divided into two groups of 36 people: one group received pioglitazone 15 mg daily and the other group received 10.5 mg daily. After grouping, pioglitazone was administered orally once a day for 6 months.Then a blood sample is taken. Fasting blood glucose levels after 8 hours of fasting, blood levels of alanine aminotransferase (ALT), triglycerides (TG), free fatty acids (FFA), and CBC, and ultrasound and in cases requiring fibroscan are measured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatullah Hospital Clinic
Full name of responsible person
Fatemeh Bahrampour
Street address
No. 24, Hakimian Alley, Badakhshan Kamali St., Abuzar St.
City
Tehran
Province
Tehran
Postal code
1363935191
Phone
+98 21 5517 3894
Email
Nemesisgrace@googlemail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad javad Behzad nia
Street address
Mulla Sadra Street, Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1363935191
Phone
+98 21 8126 7046
Email
bmcqomclinic@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Fatemeh Bahrampour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Abuzar Street, Bad Akhshan Kamali Street, No. 24, Hakimian Alley
City
Tehran
Province
Tehran
Postal code
1363935191
Phone
+98 21 5517 3894
Email
Nemesisgrace@googlemail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Fatemeh Bahrampour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Abuzar Street, Bad Akhshan Kamali Street, No. 24, Hakimian Alley
City
Tehran
Province
Tehran
Postal code
1363935191
Phone
+98 21 5517 3894
Email
Nemesisgrace@googlemail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Fatemeh Bahrampour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Abuzar Street, Bad Akhshan Kamali Street, No. 24, Hakimian Alley
City
Tehran
Province
Tehran
Postal code
1363935191
Phone
+98 21 5517 3894
Email
Nemesisgrace@googlemail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
no
When the data will become available and for how long
6 months after results are published
To whom data/document is available
No body
Under which criteria data/document could be used
no
From where data/document is obtainable
no
What processes are involved for a request to access data/document