A Comparison between the Effect of Empagliflozin and Pioglitazon on Echocardiographic Indices in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
A Comparison between the Effect of Empagliflozin and Pioglitazon on Echocardiographic Indexes in Patients with Type 2
Diabetes and Nonalcoholic Fatty Liver Disease
Design
Randomized, double-blind, Parallel-group, phase II clinical trial in 70 patients. Randomization was done through block randomization method.
Settings and conduct
Type 2 Diabetic patients with nonalcoholic fatty liver are referred to Firoozgar hospital will be randomized to two groups (A,B) and in the groups Empagliflozin and Pioglitazone will be prescribed with same coverage and researcher, patients and data analyzer will be blind to type of the drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Type 2 diabetes mellitus (T2DM); HbA1C between 7-10.5%; NAFLD with cap score >300 dB/m ;Normal Ejection Fraction (EF≥50%).
Non-inclusion criteria:
Ischemic or non Ischemic heart disease ;Current use of SGLT2 inhibitors; Current use of Thiazolidendions ;Hepatitis B; Hepatitis C; Autoimmune Hepatitis; Alcohol consumption more than 30 gr/day in men; Alcohol consumption more than 20 gr/day in women; eGFR<45 cc/min/1.73 m2.
Intervention groups
Intervention group 1:
35 patients with type 2 diabetes and NAFLD will be treated with Empagliflozin 10 milligram, once daily for 24 weeks.
Intervention group 2:
35 randomized patients with type 2 diabetes and NAFLD will be treated with Pioglitazone 30 milligram, once daily for 24 weeks.
Main outcome variables
Echocardiographic Indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190122042450N5
Registration date:2020-11-29, 1399/09/09
Registration timing:registered_while_recruiting
Last update:2020-11-29, 1399/09/09
Update count:0
Registration date
2020-11-29, 1399/09/09
Registrant information
Name
Mohammad Ebrahim Khamseh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5246
Email address
khamseh.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison between the Effect of Empagliflozin and Pioglitazon on Echocardiographic Indices in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
Public title
The cardiac effect of pioglitazone and empagliflozin among diabetic patients with NAFLD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes mellitus (T2DM)
HbA1C between 7-10.5%
Non-alcoholic fatty liver disease (NAFLD) with cap score >302 dB/m
Normal Ejection Fraction (EF≥50%)
Exclusion criteria:
ََArrhythmia
Ischemic or non Ischemic heart disease
Peripheral artery disease
Current use of SGLT2 inhibitors
Current use of Glucagone like peptide 1 receptor agonist
Current use of Thiazolidendions
Current use of Tamoxifen
Current use of Amiodarone
Current use of Nonsteroid anti inflammatory agents
Current use of Vitamin C
Current use of Vitamin E
Current use of Selenium
Current use of other antioxidants
Pregnancy
Breast feeding
Hypothyroidism
Hyperthyroidism
Cirrhosis
Hepatitis B
Hepatitis C
Autoimmune Hepatitis
Any form of chronic liver disease except fatty liver disease
Alcohol consumption more than 30 gr/day in men
Alcohol consumption more than 20 gr/day in women
eGFR<45 cc/min/1.73 m2
Corticosteroid use at least 14 days in the past month
Active cancer
History of the treated cancer in the past 2 years.
Current use of fibrates
Age
From 20 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomized by random blocking method with quadruple blocks and using a random number table of random allocation software .Blocking and allocation sequencing for concealment will be done by the non-research person.
Blinding (investigator's opinion)
Double blinded
Blinding description
Abidi's pharmaceutical company produces the empagliflozine and pioglitazone in the same package and labels them as A and B, distributes between patients by non-notified person while patient and investigator are also not informed about type of the drugs. Also, health-care and staffs of laboratory and fibroscan and echocardiography are not informed about type of drugs. Also, outcome evaluator and data analyzer are not informed about type of drugs used by each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.IUMS.REC.1398.1408
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
2
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes
3
Description of health condition studied
Cardiomyopathy
ICD-10 code
I42
ICD-10 code description
Cardiomyopathy
Primary outcomes
1
Description
Echocardiographic Indices
Timepoint
At screening time (visit 1) and 24 weeks after the start of treatment (visit 7)
Method of measurement
Echocardiograghy
Secondary outcomes
1
Description
Weight
Timepoint
At start ,after 12 weeks and 24 weeks
Method of measurement
weight scale
2
Description
Body mass index (BMI)
Timepoint
At start ,after 12 weeks and 24 weeks
Method of measurement
Calculation with formula
3
Description
Liver stiffness measurement (LSM)
Timepoint
At start and 24 weeks after intervention
Method of measurement
Liver fibroscan
4
Description
Nonalcoholic fatty liver disease fibrosis score
Timepoint
At start and 24 weeks after intervention
Method of measurement
By use of labroatary tests and formula of the NAFLD fibrosis score
5
Description
FIB4 index
Timepoint
At start and 24 weeks after intervention
Method of measurement
By use of laboratory tests and formula of the FIB4
6
Description
The change of CAP (Controlled attenuation parameter)
Timepoint
At start and 24 weeks
Method of measurement
By liver fibroscan
Intervention groups
1
Description
Intervention group 1: Empagliflozin 10 milligram, produced by Dr.Abidi pharmaceutical company, once daily for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group 2: Pioglitazone 30 milligram, once daily, produced by Dr.Abidi pharmaceutical company, for 6 months