Evaluation of incidence of metabolic abnormalities in schizophrenic patients treating with olanzapine and sitagliptin in comparison with olanzapine and placebo
Evaluation of the incidence of metabolic abnormalities in schizophrenic patients treating with olanzapine and sitagliptine in comparison with olanzapine and placebo
Design
Two arm parallel group randomised trial double blinded ,with outcome assessment
Settings and conduct
Hospitalized schizophrenic patiens in Ebnesina Hospital affliated to Shiraz Medical Sciences University,are divided randomly to two groups and followed for 12 weeks.Body mass index,waist circumference,blood lipids,blood sugar and blood pressure are measured at beginning,week 4 and week 12.
Participants/Inclusion and exclusion criteria
Hospitalized schizophrenic patients who are 18-65 years old,and treating with olanzapine.They do not have other psychiatric disorder and major medical problems.They do not use substances and they are not pregnant
Intervention groups
The placebo group and sitagliptin group receive placebo and sitagliptine for 12 weeks.Physical examination and measurement of vital signs,anthropometric charachteristics and laboratatory parameters are done at beginning,week 4 and week 12 of study
Main outcome variables
Effect of sitagliptin on body mass index,waist circumference, blood lipids,blood sugar and blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191210045677N1
Registration date:2020-01-07, 1398/10/17
Registration timing:registered_while_recruiting
Last update:2020-01-07, 1398/10/17
Update count:0
Registration date
2020-01-07, 1398/10/17
Registrant information
Name
Elahe Memari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3834 8098
Email address
elahe.memari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of incidence of metabolic abnormalities in schizophrenic patients treating with olanzapine and sitagliptin in comparison with olanzapine and placebo
Public title
Effect of sitagliptin on metabolic abnormalities in schizophrenic patients treating with olanzapine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of schizophrenia based on DSM-5 criteria and clinical interview
treating with olanzapine
Exclusion criteria:
Diagnosis of other mental disorders
Major medical problems(cardiovascular,pulmonary,gasterointestinal,renal)
Substance use
Pregnancy
Premorbid or comorbid metabolic abnormalities(obesity,diabetes,hypertension,hyperlipidemia)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in research committee of Shiraz medical school
Street address
No.75, Alley 62/5,Pasdaran Blvd
City
Shiraz
Province
Fars
Postal code
7184977879
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.SUMS.MED.REC.1397.187
Health conditions studied
1
Description of health condition studied
Metabolic abnormalities in schizophrenic patients treating with olanzapine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
blood sugar
Timepoint
At beginning,week 4 and week 12 of study
Method of measurement
Measurement of fasting blood sugar via laboratatory tests
2
Description
weight
Timepoint
At beginning,week 4 and week 12 of study
Method of measurement
weight measurement with balance
3
Description
lipid profile
Timepoint
At beginning,week 4 and week 12 of study
Method of measurement
Measurement of fasting blood lipids via laboratory tests
4
Description
Waist circumference
Timepoint
At beginning,week 4 and week 12 of study
Method of measurement
Measurement by meter
5
Description
Blood pressure
Timepoint
At beginning, week 4 and week 12 of study
Method of measurement
Measurement of blood pressure by Mercury barometer
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebnesina hospital affliated to Shiraz University of Medical Sciences
Full name of responsible person
Elahe Memari
Street address
Next to 13 Aban Garden,Hafez Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3228 9600
Email
sinahosp@sums.ac.ir
Web page address
https://ebnesina.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yoones Ghasemi PHD
Street address
7th floor, Central building of Shiraz University of Medical Sciences,Karim Khan Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Elahe Memari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No 75, Alley 62/5, Pasdaran Blvd
City
Shiraz
Province
Fars
Postal code
7184977879
Phone
+98 71 3822 4845
Email
elahe.memari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ebrahim Moghimi Sarani
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ebnesina Hospital,Next to 13 Aban Garden, Hafez Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3228 9600
Email
moghimie@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elahe Memari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No 75, Alley 62/5, Pasdaran Blvd
City
Shiraz
Province
Fars
Postal code
7184977879
Phone
+98 71 3822 4845
Email
elahe.memari@yahoo.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
Yes - There is 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
Participant data file (excluding address surname and telephone number), study protocol, statistical analysis, and clinical reports
When the data will become available and for how long
6 months after publication of the extract
To whom data/document is available
Academic researchers and affiliates with accredited research centers
Under which criteria data/document could be used
By carefully citing sources based on citation rules
From where data/document is obtainable
Sending Email to elahe.memari@yahoo.com
What processes are involved for a request to access data/document
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