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Effect of standard treatment of three drugs empagliflozin + linagliptin + metformin (trijardi xr) on BMI, lipid profile, vitamin D in type 2 diabetic patients resistant to two drugs metformin + sitagliptin, referring to the endocrinology clinic

Protocol summary

Study aim
Determining the effect of standard treatment of three drugs empagliflozin + linagliptin + metformin (trijardi xr) on BMI, lipid profile, vitamin D in type 2 diabetic patients resistant to two drugs metformin + sitagliptin
Design
In this study, the randomization process of 28 type 2 diabetic patients was not done in treatment groups, but they received the usual standard treatment. The process of randomization, random allocation of samples to groups and blinding is not done. This study does not measure the effectiveness, but shows a general review of the intervention in relation to the investigated variables.
Settings and conduct
A semi-experimental study in diabetic patients referred to the endocrinology clinic of Ganjavian Dezful Hospital
Participants/Inclusion and exclusion criteria
Conditions of entry: Patients with diabetes resistant to treatment with gliclazide or metformin, age over 18 years with BMI ≤ ≥25, HBA1C> ≤10.5, FBS<250, GFR>30, no change in treatment ≥12 weeks before the study and under treatment with metformin + sitagliptin combination drug. Exclusion conditions: GFR<30, history of recurrent urinary tract infections, history of frequent urination, BMI<25, ACS, STROKE or TIA in the past three months, bariatric surgery in the past two years, treatment with anti-obesity drugs in the past 3 months, prone to lactic acidosis or pancreatitis, type 2 diabetes One, pregnancy.
Intervention groups
At the beginning of the study, patients' FBS, HBA1C, BMI, lipid profile and vitamin D are evaluated. After the patients entered the present study, they were treated with the combined drug of empagliflozin 12.5 mg + linagliptin 2.5 mg + metformin 1000 mg for 3 months. Then, at the end of the study, by sampling the patient's blood, the mentioned variables are evaluated.
Main outcome variables
FBS; HbA1c; Lipid profile; Vitamin D; BMI.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240215061021N1
Registration date: 2024-03-10, 1402/12/20
Registration timing: registered_while_recruiting

Last update: 2024-03-10, 1402/12/20
Update count: 0
Registration date
2024-03-10, 1402/12/20
Registrant information
Name
Nasim Shirinsahrae
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4226 0683
Email address
drn.shirin1398@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of standard treatment of three drugs empagliflozin + linagliptin + metformin (trijardi xr) on BMI, lipid profile, vitamin D in type 2 diabetic patients resistant to two drugs metformin + sitagliptin, referring to the endocrinology clinic
Public title
Investigating the effect of standard treatment of three drugs empagliflozin + linagliptin + metformin (trijardi xr) on controlling blood sugar, weight, vitamin D and lipid profile of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
bmi range between 25 and 45 Patients with diabetes resistant to treatment with gliclazide or metformin Age more than 18 years Hba1c should be between 7 and 10.5 Fbs less than 250 Gfr more than 30 No change in treatment ≥12 weeks before the study be treated with metformin + sitagliptin combination drug
Exclusion criteria:
GFR<30 History of recurrent urinary tract infections History of frequent urination Bmi less than 25 ACS, STROKe or TIA in the last three months Bariatric surgery at least two years ago Be susceptible to lactic acidosis or pancreatitis Dm1 Pregnancy
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 28
More than 1 sample in each individual
Number of samples in each individual: 2
Before and after treatment
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 Dezful University of Medical Sciences
Street address
Azadegan St., Dezful University of Medical Sciences
City
Dezful
Province
Khouzestan
Postal code
6461669969
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.DUMS.REC.1402.061

Health conditions studied

1

Description of health condition studied
type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
before the start of the study and three months after the start of treatment
Method of measurement
Measurement through variable measurement by laboratory diagnostic kit

2

Description
HbA1c
Timepoint
before the start of the study and three months after the start of treatment
Method of measurement
Measurement through variable measurement by laboratory diagnostic kit

Secondary outcomes

1

Description
Lipid profile
Timepoint
before the start of the study and three months after the start of treatment
Method of measurement
Measurement through variable measurement by laboratory diagnostic kit

2

Description
Vitamin D
Timepoint
before the start of the study and three months after the start of treatment
Method of measurement
Measurement through variable measurement by laboratory diagnostic kit

3

Description
BMI
Timepoint
before the start of the study and three months after the start of treatment
Method of measurement
How to calculate BMI: Weight (kg) / height squared (m2) BMI

Intervention groups

1

Description
At the beginning of the study, patients' FBS, HBA1C, BMI, lipid profile and vitamin D are evaluated. After the patients entered the present study, they were treated with the combined drug of empagliflozin 12.5 mg + linagliptin 2.5 mg + metformin 1000 mg for 3 months. Then, at the end of the study, by sampling the patient's blood, FBS, HBA1C, lipid profile, vitamin D and BMI variables are evaluated again through calculation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine Clinic of Ganjavian Dezful Hospital
Full name of responsible person
Dr. Hamid Karimi
Street address
Azadegan St.
City
Dezful
Province
Khouzestan
Postal code
6461669969
Phone
+98 61 4242 2040
Email
drn.shirin1398@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amin Behmanesh
Street address
Azadegan St. Dezful University of Medical Sciences
City
Dezful
Province
Khouzestan
Postal code
6461669969
Phone
+98 61 4242 8717
Email
drn.shirin1398@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezfoul 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
Dezfoul University of Medical Sciences
Full name of responsible person
Nasim Shirinsahrae
Position
Internal resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Azadegan St. Ganjavian Dezful Hospital
City
Dezful
Province
Khouzestan
Postal code
6461669969
Phone
+98 61 4242 2040
Fax
Email
drn.shirin1398@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Nasim Shirinsahrae
Position
Internal resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Azadegan St. Ganjavian Dezful Hospital
City
Dezful
Province
Khouzestan
Postal code
6461669969
Phone
+98 61 4242 2040
Fax
Email
drn.shirin1398@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Nasim Shirinsahrae
Position
Internal resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Azadegan St. Ganjavian Dezful Hospital
City
Dezful
Province
Khouzestan
Postal code
6461669969
Phone
+98 61 4242 2040
Fax
Email
drn.shirin1398@gmail.com

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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the results obtained from the laboratory tests can and will be published scientifically. Personal information of individuals is not published based on confidentiality rules.
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
If the present research project is continued in future studies by other university researchers, the results of data analysis will be provided to them.
From where data/document is obtainable
Dr. Nasim Shirinsahraee Email: drn.shirin1398@gmail.com
What processes are involved for a request to access data/document
Submission of an official letter from the research vice-chancellor of the university or research center with the final approval of the ministers to the vice-chancellor of education, research and technology of Dezful University of Medical Sciences. The time required to submit the requested document is 1 month.
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