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IRCT20191210045677N1 IRCT 2020-01-07 Shiraz University of Medical Sciences Effect of sitagliptin on metabolic abnormalities in schizophrenic patients treating with olanzapine Evaluation of incidence of metabolic abnormalities in schizophrenic patients treating with olanzapine and sitagliptin in comparison with olanzapine and placebo 2019-12-22 anticipated 80 Complete https://irct.ir/trial/44087 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with random number table.In this method, individuals are numbered from 1 to n (number of sample ) without sequencing to have an equal chance each individual.Then, in the random number table provided by the computer, a number is randomly selected as the source of the sample and, given the position of the number in the table (rows and columns), rows of n numbers are considered.The numbers in the selected rows are read in order n The number corresponding to the community numbering indicates the row number of people to be selected in the sample.A proportional number is a number that is between 1 and n. Each repeated number is counted only once and the numbers outside the range n are deleted. Drugs are numbered in similar envelopes depending on the order of assignment, and it is important to note that the envelopes are opened periodically and after the participant's name is inserted.Patients are assigned to a target group by a person other than the researcher (for example, the head of the inpatient ward), and the list is kept, Blinding description: The tablets have the same shape and color.They are distributed randomly among the patients.The researcher,patients,data analyzer and data safety and monitoring committee are not aware of each patient s medication. 3 Metabolic abnormalities in schizophrenic patients treating with olanzapine. Intervention 1: Intervention group: Prescription of 100 mg tablets of Sitagliptin manufactured by Dr. Abidi Pharmaceutical Company with daily use of 1 tablet for 12 weeks and measurement of body mass index,waist circumference,blood pressure,fasting blood sugar and lipid profile at beginning,week 4 and week 12 of study. Intervention 2: Control group: Prescription of placebo tablets made by the Faculty of Pharmacy, Shiraz University of Medical Sciences,one tab daily for 12 weeks.Body mass index, waist circumference, blood pressure, fasting blood glucose, and fasting lipid profile are measured at baseline, after 4 weeks, and after 12 weeks. Yes - There is a plan to make this available What will be shared: Participant data file (excluding address surname and telephone number), study protocol, statistical analysis, and clinical reports When: 6 months after publication of the extract To whom: Academic researchers and affiliates with accredited research centers Conditions: By carefully citing sources based on citation rules Where to obtain: Sending Email to elahe.memari@yahoo.com How to obtain: Send email that includs precise personal information and purpose of data usage, review of request by academic, financier and researcher for approximately one month, submission of data file upon request approval Comments:
public Elahe Memari
No 75, Alley 62/5, Pasdaran Blvd
Shiraz Iran (Islamic Republic of) 7184977879 +98 71 3822 4845 elahe.memari@yahoo.com Shiraz University of Medical Sciences scientific Ebrahim Moghimi Sarani
Ebnesina Hospital,Next to 13 Aban Garden, Hafez Avenue
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3228 9600 moghimie@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of schizophrenia based on DSM-5 criteria and clinical interview treating with olanzapine 18 years 65 years Both Diagnosis of other mental disorders Major medical problems(cardiovascular,pulmonary,gasterointestinal,renal) Substance use Pregnancy Premorbid or comorbid metabolic abnormalities(obesity,diabetes,hypertension,hyperlipidemia) Treatment - Drugs Placebo Intervention group: Prescription of 100 mg tablets of Sitagliptin manufactured by Dr. Abidi Pharmaceutical Company with daily use of 1 tablet for 12 weeks and measurement of body mass index,waist circumference,blood pressure,fasting blood sugar and lipid profile at beginning,week 4 and week 12 of study Control group: Prescription of placebo tablets made by the Faculty of Pharmacy, Shiraz University of Medical Sciences,one tab daily for 12 weeks.Body mass index, waist circumference, blood pressure, fasting blood glucose, and fasting lipid profile are measured at baseline, after 4 weeks, and after 12 weeks. Blood sugar. Timepoint: At beginning,week 4 and week 12 of study. Method of measurement: Measurement of fasting blood sugar via laboratatory tests. Weight. Timepoint: At beginning,week 4 and week 12 of study. Method of measurement: weight measurement with balance. Lipid profile. Timepoint: At beginning,week 4 and week 12 of study. Method of measurement: Measurement of fasting blood lipids via laboratory tests. Waist circumference. Timepoint: At beginning,week 4 and week 12 of study. Method of measurement: Measurement by meter. Blood pressure. Timepoint: At beginning, week 4 and week 12 of study. Method of measurement: Measurement of blood pressure by Mercury barometer. . Timepoint: . Method of measurement: . Shiraz University of Medical Sciences Approved 2018-07-29 Ethics in research committee of Shiraz medical school No.75, Alley 62/5,Pasdaran Blvd Shiraz Fars Iran (Islamic Republic of)