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Investigating the effect of empagliflozin on the serum level of glycosylated hemoglobin in patients with type 2 diabetes

Protocol summary

Study aim
Determining the effect of empagliflozin glucose on the serum level of glycosylated hemoglobin in patients with type 2 diabetes
Design
Clinical trial with an intervention group
Settings and conduct
This study is conducted in Waliasr Hospital, Birjand, South Khorasan Province. 45 diabetic patients living in the city of Birjand referring to the diabetes clinic and the specialized clinic of Valiasr Birjand hospital in 1403 are included in the study.
Participants/Inclusion and exclusion criteria
Our study population will be diabetic patients living in the city of Birjand referring to the diabetes clinic and the specialized clinic of Valiasr Hospital in Birjand in 1402. Inclusion criteria: patients with type 2 diabetes, having diabetes for at least 6 months, patients treated with oral medication, glycosylated hemoglobin below 10 and above 8, previous treatment of the patient with 2 grams of metformin and lack of appropriate treatment response, and exclusion criteria Study: Patients consuming minerals, vitamins or antioxidants or medicinal herbs, pregnant or lactating women, patients with heart failure, having chronic diseases such as rheumatology, thyroid problems, whether hypothyroid or hyperthyroid, patients receiving NPH insulin (aspartate, lispro) and glargine) and regular and patients with kidney failure, chronic kidney disease (CKD) (GFR > 30 ml/min), liver and patients undergoing treatment for gastrointestinal diseases.
Intervention groups
45 diabetic patients living in the city of Birjand referred to the diabetes clinic and specialized clinic of Waliasr Hospital in Birjand in 1403.
Main outcome variables
Fasting blood sugar (FBS)؛ Glycosylated hemoglobin (HbA1C)؛ Blood sugar 2 hours after eating (2hhp)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043934N30
Registration date: 2024-11-14, 1403/08/24
Registration timing: prospective

Last update: 2024-11-14, 1403/08/24
Update count: 0
Registration date
2024-11-14, 1403/08/24
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of empagliflozin on the serum level of glycosylated hemoglobin in patients with type 2 diabetes
Public title
Investigating the effect of empagliflozin on the serum level of glycosylated hemoglobin in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes Having diabetes for at least 6 months Patients treated with oral medication Glycosylated hemoglobin below 10 and above 8 Previous treatment of the patient with 2 grams of metformin and lack of adequate treatment response
Exclusion criteria:
Patients consuming minerals, vitamins or antioxidants or medicinal plants Pregnant or lactating women A patient with heart failure Having a chronic disease such as rheumatology diseases Thyroid problems, whether hypothyroid or hyperthyroid Patients receiving NPH insulin (aspartate, lispro and glargine) and regular Patients with kidney failure, chronic kidney disease (GFR > 30 ml/min), liver failure and patients undergoing treatment for gastrointestinal diseases
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2024-10-28, 1403/08/07
Ethics committee reference number
IR.BUMS.REC.1403.265

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
In serum samples of patients using the Bionic company kit

2

Description
Glycosylated hemoglobin
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
In serum samples of patients using the Bionic company kit

3

Description
Fasting blood sugar 2 hours after eating
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
In serum samples of patients using the Bionic company kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The number of 45 diabetic patients living in Birjand city will refer to the diabetes clinic and specialized clinic of Valiasr Birjand hospital in 1403.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Birjand Hospital
Full name of responsible person
Dr Razieh Ayati
Street address
Valiasr Hospital Diabetes Clinic. Ghafari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
Valiasrhospital@bums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Masoud Yousefi
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Shaghayesgh Aghasizadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand, South Khorasan, Iran
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Razieh Ayati
Position
Student
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
ayatirazieh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
zabihullahmohaghegh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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