Investigating the effect of empagliflozin on blood sugar control, edema, electrolytes and hypertension in diabetic hemodialysis patients
Design
This study is a randomized clinical trial with a parallel design and a control group. This blinded and randomized study will be conducted on at least 134 diabetic hemodialysis patients. A simple random method is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in Imam Reza Hospital in Kermanshah, is blinded. In both studied groups, blood sugar, diuresis (urine volume), water, and electrolytes are recorded by the resident before entering the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Hemodialysis patients with a history of diabetes
Exclusion criteria:Patients with any history of empagliflozin allergy
Intervention groups
In the intervention group, empagliflozin 10 mg (low dose) is prescribed every other day to the patients under the supervision of a specialist doctor for a month, and the desired changes in the patients are checked every week and finally recorded at the end of the first month. If there are no special complications for the patients, the drug dose will be increased in the next month and the desired changes will be recorded at the end of the second month. The control group will receive routine treatment
Main outcome variables
Blood sugar, diuresis (urine volume), water and electrolytes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N217
Registration date:2024-06-11, 1403/03/22
Registration timing:registered_while_recruiting
Last update:2024-06-11, 1403/03/22
Update count:0
Registration date
2024-06-11, 1403/03/22
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-01, 1403/03/12
Expected recruitment end date
2024-12-02, 1403/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of empagliflozin on blood sugar control, edema, electrolytes and hypertension in diabetic hemodialysis patients
Public title
Investigating the effect of empagliflozin on blood sugar control, edema, electrolytes and hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Hemodialysis patients with a history of diabetes
Exclusion criteria:
History of allergy to empagliflozin
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method. 134 cards are selected and numbers from 1-134 are inserted on the cards. The cards are placed in an envelope. Two of the design partners take one card out of the envelope each time and announce the card number. Paired numbers are assigned to the intervention group and odd numbers to the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.KUMS.MED.REC.1403.017
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Blood sugar
Timepoint
Before starting the study, one month and two months after the end of the study
Method of measurement
Based on laboratory results
2
Description
Diuresis (volume of urine)
Timepoint
Before starting the study, one month and two months after the end of the study
Method of measurement
Based on laboratory results
3
Description
Water
Timepoint
Before starting the study, one month and two months after the end of the study
Method of measurement
Based on laboratory results
4
Description
Electrolyte
Timepoint
Before starting the study, one month and two months after the end of the study
Method of measurement
Based on laboratory results
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, empagliflozin 10 mg (low dose) is prescribed every other day to the patients under the supervision of a specialist doctor for a month, and the desired changes in the patients are checked every week and finally recorded at the end of the first month. If there are no special complications for the patients, the drug dose will be increased in the next month and the desired changes will be recorded at the end of the second month.
Category
Treatment - Drugs
2
Description
The control group will receive routine treatment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Pegah Khodadadian
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
P.khodadadian89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sima Golmohammadian
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
s.golmohammadi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sima Golmohammadi
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
s.golmohammadi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Pegah Khodadadian
Position
Resident of internal
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
P.khodadadian89@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD