Protocol summary
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Study aim
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investigating the effect of empagliflozin on non-alcoholic fatty liver in type 2 diabetic patients referred to Loghman Hakim Hospital in 1400
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Design
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Sampling method:
The non-probability sampling method will be targeted. In this way, random method is not used in selecting patients in each group, but from the available patients, patients in each group will be selected based on the researcher's judgment up to the specified volume (70 people in each group) according to the purpose of the study.
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Settings and conduct
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The present study, after obtaining permission from the ethics committee of Shahid Beheshti University of Medical Sciences and the consent of the head of the internal department of Loghman Hakim Hospital, will be conducted as a clinical trial on 140 type 2 diabetic patients referred to the endocrine / diabetes / gastrointestinal clinic in 1400. Patients are equally divided into control and treatment groups. In the treatment group, in addition to the standard treatment, they will receive 10 mg of Empagliflozin daily for 6 months. In the control group, patients received only standard treatment and did not receive Empagliflozin.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patients with type 2 diabetes in the age group of 20 to 70 years who are candidates for treatment with Empagliflozin.
No history of Empagliflozin use
-GFR> 35ml / min / 1.73mn2
-HbA1c≤7.5%
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Intervention groups
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Patients with type 2 diabetes and fatty liver treated with empagliflozin and placeo
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Main outcome variables
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Practical goals:
1.determining the level of insilin level,alt,ast,alkp,GGT,billi,FBS,HbA1c before and 3 and 6 months after the start of treatment
2.determining the degree of fatty liver by U.S and MRI before and 3 and 6 months after start if treatment
3.determining weigt and BMI before and 3 and 6 months after start of teratment
General information
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Reason for update
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Due to the spread of corona virus and lack of regular visits of patients to the clinic and the lack of a trend to treat diabetes with pioglitazone,the control group was tested with a placebo drug instead of pioglitazone,which did not contain empagliflozin and was prepared by a pharmaceutical company and available to type 2 diabetes patients with non alcoholics fatty liver who were under standard diabetes treatment.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210811052150N1
Registration date:
2023-01-28, 1401/11/08
Registration timing:
retrospective
Last update:
2023-04-16, 1402/01/27
Update count:
1
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Registration date
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2023-01-28, 1401/11/08
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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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2021-08-11, 1400/05/20
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Expected recruitment end date
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2022-05-10, 1401/02/20
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Actual recruitment start date
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2021-08-11, 1400/05/20
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Actual recruitment end date
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2022-03-11, 1400/12/20
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Trial completion date
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2022-09-11, 1401/06/20
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Scientific title
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The effect of Empagliflozine on the Non-Alcoholic Fatty Liver Disease in patients with type 2 diabetes mellitus
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Public title
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effect of Empagliflozine on the Non-Alchoholic Fatti Liver Disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with type 2 diabetes in the age group of 20 to 70 years who are candidates for treatment with Empagliflozine
No history of using Empaglifozine
GFR>35ml/min/1.7m2
HbA1c≤7.5%
Satisfaction of patients or their legal guardians to attend the study and continue it
Exclusion criteria:
History of advanced liver and kidney disease
Cardiac surgery or angioplasty planned within the last 3 months
Bariatric surgery in last 2 years and other gastrointestinal surgeries that cause chronic malabsorotion
Bleeding or any disorder in causing hemolysis or unstable red blood cells(such as malaria)
Medical history of cancer(except basal cell cancer)or cancer treatment in the last 5 years
treatment with anti-obesity drugs in the 3 months prior ti informed consent or any other treatment at the time of screening(i.e. surgery;aggressive dieting;etc)that results in an unstable body weight
current treatment with systemic steroids or any uncontrolled endocrine disorder other than type 2 diabetes
cinsumtion of alcohol or drugs in the last 3 months
patients who during the treatment,another drug to control blood sugar was added to their teatment
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Age
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From 20 years old to 70 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
140
Actual sample size reached:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be simple and for each patient according to labeling initial amounts of the placebo (control group) and Empagliflozine(treatment group),using a randomizednumber chart.these same numbers will be written and sealed,and placed in a box for allocation concealment.The course of treatment for each patient will be selected by choosing the random numbers concealed in the box at the beginning of the study.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study,blinding will e done for the patients as well aspart of the researchers who have the role of clinical caregivers and outcome assessors by coding packages containing empagliflozin and placebo which are apparently the same.Then these codes will be the number of patients in one envelope,will be cast and chosen randomaly.
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Placebo
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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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2021-08-10, 1400/05/19
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Ethics committee reference number
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IR.SBMU.MSP.REC.1400.287
Health conditions studied
1
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Description of health condition studied
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Non-Alchoholic Fatty Liver Disease
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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)
Primary outcomes
1
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Description
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Degree of fatty liver in MRI
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Timepoint
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Before treatment and six months after treatment
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Method of measurement
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MRI
2
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Description
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body mass index
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Timepoint
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before and three and six monthns after treatment
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Method of measurement
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Kg/m2
3
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Description
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fasting blood sugar
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Timepoint
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before and three and six months after treatmen
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Method of measurement
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blood sampling
4
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Description
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HbA1C
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Timepoint
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before and three and six months after teatment
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Method of measurement
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blood sampling
5
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Description
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the level of liver transaminases
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Timepoint
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before and three and six months after treatmenet
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Method of measurement
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blood sampling
Intervention groups
1
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Description
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Intervention group: Patients with Non-Alcoliholic Fatty Liver disease and type 2 Diabetes are under intervention with Empagliflozine at a dose of 10 and 25 mg based on FBS and HbA1c for 6 months and after 3 and 6 months in terms of FBS,HbA1c,AST,ALT,ALKP and degree of fatty liver they are examined in MRI and ultrasound.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients with Non-Alcoliholic Fatty Liver disease and type 2 Diabetes under standard diabetes treatment with placebo drug that did not contain empagliflozin based on FBS and HbA1c are monitored for 6 months in terms of FBS,HbA1c,AST,ALT,ALKP and liver grade fat is checked in MRI and ultrasound
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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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Shahid Beheshti 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available