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IRCT20240215061021N1 IRCT 2024-03-10 Dezfoul University of Medical Sciences 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 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 2024-02-20 anticipated 28 Complete https://irct.ir/trial/75542 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 type 2 Diabetes. 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.. Yes - There is a plan to make this available What will be shared: 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: 6 months after the publication of the article To whom: Academic and scientific researchers Conditions: If the present research project is continued in future studies by other university researchers, the results of data analysis will be provided to them. Where to obtain: Dr. Nasim Shirinsahraee Email: drn.shirin1398@gmail.com How to obtain: 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. Comments:
public Nasim Shirinsahrae
Azadegan St. Ganjavian Dezful Hospital
Dezful Iran (Islamic Republic of) 6461669969 +98 61 4242 2040 drn.shirin1398@gmail.com Dezfoul University of Medical Sciences scientific Nasim Shirinsahrae
Azadegan St. Ganjavian Dezful Hospital
Dezful Iran (Islamic Republic of) 6461669969 +98 61 4242 2040 drn.shirin1398@gmail.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 E11 Type 2 diabetes mellitus Treatment - Drugs 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. 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. 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. 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. 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. 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. Dezfoul University of Medical Sciences Approved 2024-02-05 Ethics committee of Dezful University of Medical Sciences Azadegan St., Dezful University of Medical Sciences Dezful Khouzestan Iran (Islamic Republic of)