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A comparative analysis of effects of empagliflozin whit metformin on cardiometabolic factors and blood glucose of prediabetic patients

Protocol summary

Study aim
Comparison of average blood sugar indices (fasting blood sugar, fasting insulin, HbA1C, HOMA-Ir) and cardiometabolic factors (uric acid, cholesterol, triglyceride, HDL, LDL, CRP) of patients with prediabetes in three groups of metformin users 500 mg and empagliflozin 25 mg and empagliflozin 10 mg
Design
The clinical trial has three intervention groups, with parallel groups, double-blind, randomized with random allocation software, on 90 patients.
Settings and conduct
Imam Ali Shahrekord clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: pre-diabetic people aged 17-65 years whose pre-diabetes status has been newly diagnosed or has not yet been treated. Exclusion criteria: known cases of diabetes, history of urinary tract infection
Intervention groups
The study group includes hyperdiabetics (IFG and IGT) who were randomly divided into three intervention groups A, B, and C, and one intervention group received 500 mg of metforin, the other group received empagliflozin 25 mg, and the other group received empagliflozin. 10 mg is allocated
Main outcome variables
FBS; LDL; HDL CRP; TG; Cholesterol; Uric acid; Serum Fasting Insulin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220902055858N1
Registration date: 2022-09-24, 1401/07/02
Registration timing: registered_while_recruiting

Last update: 2022-09-24, 1401/07/02
Update count: 0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Amin Moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3365 8225
Email address
amin.moosavi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative analysis of effects of empagliflozin whit metformin on cardiometabolic factors and blood glucose of prediabetic patients
Public title
Effect of Empagliflozin in Prediabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Prediabetic Patient Age 17 to 65 years Not receiving blood sugar-lowering drugs
Exclusion criteria:
Known case of Diabetes A history of urinary tract infection
Age
From 17 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomized using random allocation software. In the software, the number of groups and the number of samples and the type of groups are determined. Then the numbers 1 to 90 are randomly assigned to three intervention groups. Group A, B and C; All three groups are subject to intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be divided into three intervention groups (A, B, C) using random allocation software. Then envelopes are prepared according to the number of people participating in the study and numbers 1 to 90 are written on the envelopes and placed in each envelope using A, B and C software. In this way, when each person enters, a special envelope is opened for that person and according to the option inside the envelope, the person is assigned to one of the three intervention groups. The patients are not aware of the group to which they belong until the end of the study. The intervention will be done by someone other than the researcher.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Hajar Hospital, Parastar Ave., Kashani Blvd., Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2022-06-22, 1401/04/01
Ethics committee reference number
IR.SKUMS.MED.REC.1401.025

Health conditions studied

1

Description of health condition studied
Impaired fasting glucose
ICD-10 code
R73.01
ICD-10 code description
Impaired fasting glucose

2

Description of health condition studied
Impaired glucose tolerance
ICD-10 code
R73.02
ICD-10 code description
Impaired glucose tolerance (oral)

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
Measurement of fasting blood sugar at the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Peripheral blood biochemistry sample

2

Description
Postprandial blood sugar
Timepoint
Measurement of Postprandial blood sugar at the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Peripheral blood biochemistry sample

3

Description
Glycosylated hemoglobin
Timepoint
Measurement of Glycosylated hemoglobin at the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Peripheral blood biochemistry sample

4

Description
Uric Acid level
Timepoint
Measurement of Uric Acid at the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Peripheral blood biochemistry sample

5

Description
C-Reactive Protein (CRP)
Timepoint
Measurement of CRP at the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Peripheral blood biochemistry sample

6

Description
cholesterol
Timepoint
Measurement of cholesterol at the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Peripheral blood biochemistry sample

7

Description
Low Density Lipoprotein (LDL)
Timepoint
Measurement of LDL at the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Peripheral blood biochemistry sample

8

Description
High Density Lipoprotein (HDL)
Timepoint
Measurement of HDL at the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Peripheral blood biochemistry sample

9

Description
Fasting Insulin Level
Timepoint
Measurement of Fasting Insulin Level at the beginning of the study and 12 weeks after the start of the intervention
Method of measurement
Peripheral blood biochemistry sample

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Prediabetic patients receiving metformin 500 mg twice a day ABIDI.Co for 3 months
Category
Treatment - Drugs

2

Description
Intervention group: Prediabetic patients receiving empagliflozin 10 mg once a day َABIDI.Co for 3 months
Category
Treatment - Drugs

3

Description
Intervention group: Prediabetic patients receiving empagliflozin 25 mg once a day َABIDI.Co for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Subspecialty clinic
Full name of responsible person
Amin Moosavi
Street address
Shariati Ave., Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3224 2696
Email
info@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Kashani Blvd., Headquarters of Shahrekord University of Medical Science
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Amin Moosavi
Position
Resident of medical science
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.14, 3rd Andisheh Ave., Molasadra Blvd
City
Qazvin
Province
Chahar-Mahal-va-Bakhtiari
Postal code
3415834937
Phone
+98 38 3365 8225
Fax
Email
amin.moosavi@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Amin Moosavi
Position
Resident of medical science
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.14, 3rd Andisheh Ave., Molasadra Blvd
City
Qazvin
Province
Chahar-Mahal-va-Bakhtiari
Postal code
3415834937
Phone
+98 38 3365 8225
Fax
Email
amin.moosavi@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Amin Moosavi
Position
Resident of medical science
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.14, 3rd Andisheh Ave., Molasadra Blvd
City
Qazvin
Province
Chahar-Mahal-va-Bakhtiari
Postal code
3415834937
Phone
+98 38 3365 8225
Fax
Email
amin.moosavi@skums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Dr. Golshan Taghipur
Under which criteria data/document could be used
After printing the data results can be used.
From where data/document is obtainable
Data can be used by referring to e-mail.
What processes are involved for a request to access data/document
The access period starts 6 months after the results are published.
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