The primary outcome is determining the effect of empagliflozin on liver enzymes and the secondary outcomes include determining the effect of empagliflozin on lipid profile and indicators of metabolic syndrome in patients with type 2 diabetes and nonalcoholic steatohepatitis.
Design
Phase three double-blind, randomized clinical trial with a control group, with parallel groups, on 110 patients, randomization was done with website "sealedenvelope.com"
Settings and conduct
The study will recruit in Ayatollah Rouhani Hospital of Babol and Omid Babol Special Clinic. Sampling will be done among available eligible people. Each patient will be assigned a special code based on a random list and the patient will be placed in the intervention or control group based on it. The patient, the physician in charge of the plan, the person in charge of patient recruitment and registration of patient information, the person in charge of evaluating the study parameters, and the data analyst are all blind to the patient group and only know the code assigned to each person. One of the researchers in the group, who has no role in the patient recruitment, treatment and evaluation of the study parameters, has access to a random list containing the patient's specific code and the corresponding treatment.
Participants/Inclusion and exclusion criteria
Study population: Type 2 diabetic patients with non-alcoholic steatohepatitis
inclusion criteria: age between 18 to 85 years old, body mass index less than 35 kg per square meters
Intervention groups
Intervention group: Standard treatment for type 2 diabetes with one empagliflozin 10 mg tablet daily
Control group: Standard treatment for type 2 diabetes with one placebo tablet daily
Effect of Empagliflozin on Liver Enzymes level in type two Diabetic Patients with Non-Alcoholic Steatohepatitis
Public title
Effect of Empagliflozin in diabetic patients with non-alcoholic steatohepatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index less than 35 Kg/mm
No history of chronic alcohol usage
No history of viral hepatities
No history of autoimmune hepatitis
No history of drug-induced hepatitis
No history of chronic usage of hepatic-steatosis-induced drugs(e.g.: Amiodarone, Valproate, Tamoxifen, Methotrexate, Glucocorticoids)
No history of chronic usage of Thiazolidines and GLP-1 agonists
Absence of evidence suggestive for cirrhosis based on physical examination, laboratory evaluation, and imaging studies
Absence of evidence suggestive for Hepatocellular carcinoma based on physical examination, laboratory evaluation, and imaging studies
Non pregnant women
No previous history of HELLP syndrome in women
No history of chronic kidney disease
No history of chronic usage of Omega-3 containing supplements
No contraindication for Empagliflozin usage (e.g.: history of recurrent genitourinary tract infection, gangrene, history of allergic reaction to the drug, serum Trigliceride level more than 500 mg/dl)
Exclusion criteria:
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
We will assign each person to one of the two study groups in a one-to-one ratio using the random block method. Using the site www.sealedenvelope.com, with seed number 186476011923636 and block size 4 and the length of the list 110 and the code specific to each person, we made a random list, which we gave to a member of the research team who has no role in patient recruitment and data analysis. The person in charge of patients recruitment will call the person who has a random list and receive a code specific to the patient and assign it to the patient. The treatment protocol will be performed based on the code assigned to The patient. The person in charge of the patient's follow-up and data analysis will not be aware of the treatment protocol used for that person.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant will be kept blind from receiving a drug or placebo by using a placebo with the same shape, color, and size as the drug.
The clinician only knows the code assigned to the patient and does not know the patient's treatment.
Only one researcher from the research team, who has no role in patient recruitment and data analysis, has access to the randomization list containing each individual's specific code and treatment protocol and does not reveal it to anyone except in life-threatening cases or based on the decision of the university ethics committee.
The outcome assessor only has access to the code assigned to the patient and does not know the treatment protocol of that code.
The data analyzer does not know each patient's treatment protocol, and we will provide the coded data to him.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Approval date
2021-08-31, 1400/06/09
Ethics committee reference number
IR.MUBABOL.REC.1400.186
Health conditions studied
1
Description of health condition studied
non-alcoholic steatohepatitis
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Aspartate transaminase
Timepoint
Before the start of the study, 12 and 24 weeks after the start of treatment
Method of measurement
Serum level measurement
2
Description
Alanine transaminase
Timepoint
Before the start of the study, 12 and 24 weeks after the start of treatment
Method of measurement
Serum level measurement
3
Description
Alkaline phosphatase
Timepoint
Before the start of the study, 12 and 24 weeks after the start of treatment
Method of measurement
Serum level measurement
4
Description
body weight
Timepoint
Before the start of the study, 12 and 24 weeks after the start of treatment
Method of measurement
Using scales and in kilograms
5
Description
weight cirmucfrences
Timepoint
Before the start of the study, 12 and 24 weeks after the start of treatment
Method of measurement
Using meters and in centimeters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Standard treatment for type 2 diabetes with one 10 mg Empagliflozin tablet daily
Category
Treatment - Drugs
2
Description
Control group: Standard treatment for type 2 diabetes with one placebo tablet daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital of Babol
Full name of responsible person
Neda Meftah
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
n.meftah@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/
2
Recruitment center
Name of recruitment center
Omid Therapy Clinic
Full name of responsible person
Neda Meftah
Street address
Omid Medical Clinic, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3233 8301
Email
n.meftah@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?