Protocol summary
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Study aim
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Determining the effects of metformin and glorenta (empagliflozin and linaglyptin) on fatty liver in patients with type 2 diabetes
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Design
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Clinical trial with control group and intervention group, non-blind, simple randomized, phase 3 per 100 patients. For simple randomization of sealed envelopes containing blue and red cards that are randomly given to participants
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Settings and conduct
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Patients who refer to the hospital and the office of physicians specializing in gastroenterology and endocrinology and the objectives of the research are explained to them and if patients wish, they will enter the research.
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Participants/Inclusion and exclusion criteria
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1- Willingness to cooperate and complete the informed consent form by the patient
2- Patients over 18 years old
3- No pregnancy and breastfeeding
4- Do not consume alcohol
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Intervention groups
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The first group or the control group will receive standard treatment with metformin 500 mg tablets
The second group receives Glorenta tablets, which are a combination of 25 mg empagliflozin and 5 mg linagliptin.
Patients will take the medication regimen for 12 weeks (3 months) and will be followed up
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Main outcome variables
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1- Further reduction in FBS and HBA1C
2- Further reduction in patients' weight and BMI
3- Further reduction in ALT enzyme levels
General information
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Reason for update
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Change sampling time
Change the test time in the primary and secondary outcome variables
Changing the number of pills in control and intervention groups
Lack of sufficient number of patients to collect
Increase the duration of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210922052550N1
Registration date:
2021-11-07, 1400/08/16
Registration timing:
prospective
Last update:
2022-07-23, 1401/05/01
Update count:
3
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Registration date
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2021-11-07, 1400/08/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-11-11, 1400/08/20
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Expected recruitment end date
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2022-09-22, 1401/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effects of Metformin and glorenta (Empagliflozin and linagliptin) on fatty liver of patients with type 2 diabetes in Ilam in 2021
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Public title
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Comparison of the effects of metformin and glorenta on fatty liver in patients with type 2 diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to cooperate and complete the informed consent form by the patient
Patients over 18 years of age
No pregnancy and lactation
Do not drink alcohol
Exclusion criteria:
Kidney disease
Drugs sensitivity
Diabetic ketoacidosis
Exfoliative dermatitis and angioedema
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are divided into two groups by simple randomization with a sealed envelope. There are blue and red cards in the envelopes. Group 1 receives blue cards and the second group receives red cards randomly.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-04, 1400/07/12
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Ethics committee reference number
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IR.MEDILAM.REC.1400.119
Health conditions studied
1
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Description of health condition studied
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Fatty liver of type 2 diabetic patients
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
2
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Description of health condition studied
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Fatty liver of type 2 diabetic patients
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ICD-10 code
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E88.81
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ICD-10 code description
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Metabolic syndrome
3
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Description of health condition studied
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Fatty liver of type 2 diabetic patients
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ICD-10 code
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K75.81
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ICD-10 code description
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Nonalcoholic steatohepatitis (NASH)
4
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Description of health condition studied
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Fatty liver of type 2 diabetic patients
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ICD-10 code
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E08
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ICD-10 code description
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Diabetes mellitus due to underlying condition
Primary outcomes
1
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Description
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Determination and comparison of serum levels of alanine aminotransferase at the beginning and end of the study
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Timepoint
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Measurement of serum levels of alanine aminotransferase at the beginning of the study and three month later
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Method of measurement
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Serum levels of Alanine aminotransferase will be measured by a reagent laboratory and results will be obtained.
Secondary outcomes
1
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Description
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Determining and comparing the ratio of abdominal circumference to hip circumference at the beginning and end of the study
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Timepoint
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Measure the ratio of abdominal circumference to hip circumference at the beginning of the study and three month later
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Method of measurement
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Measure the ratio of abdominal circumference to hip circumference using an inelastic meter
2
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Description
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Determining and comparing ultrasound findings at the beginning and end of the study
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Timepoint
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Perform ultrasound at the beginning of the study and three months later
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Method of measurement
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Perform ultrasound by the selected ultrasound center and get the results
Intervention groups
1
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Description
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Control group: will receive metformin tablets, daily use (once) , drug dose: 500 mg, duration of use 12 weeks, number: 90 tablets, how to use: with breakfast, number of use: one daily, manufacturer : Amin Pharmaceutical Company
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Category
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Treatment - Drugs
2
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Description
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Intervention group: will receive glorenta tablets, composition: ampagliflozin 25 mg and linagliptin 5 mg, dose: 25/5mg, number of drugs: 90, how to use: with food, number of times: one daily tablet , Duration of use: 12 weeks, Manufacturer: Abidi Pharmaceutical Company
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ilam University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information on the main outcome and outcome of the study
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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People related to medicine and pharmacy
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Under which criteria data/document could be used
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In other subjects, using the results of this plan, the results can be used
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From where data/document is obtainable
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Ilam University of Medical Sciences data center and request by email to the project implementer
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What processes are involved for a request to access data/document
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After receiving the email from the applicant, the project manager will respond
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Comments
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