compare the insulin glargine and detemir on hormone factors affecting appetite in type 1 diabetic patients
Design
A simple randomization (according to table of random number), with a 2 parallel group, N=41 (first intervention group1 n=21 second intervention group n=20), Not blinded, Phase 3
Settings and conduct
A total of 41 children with new case of type 1 diabetes under 18 years that hospitalized in Ali Asghar Children's Hospital in April to August 2019. Patients were randomly assigned into two groups as insulin Glargine (n=21) and insulin Detemir(n=20) during 3 months. Insulin was given by subcutaneous injection at 30-50% of the patient's daily requirement (according to age and clinical response).
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Parent's Consent to participate in this study, new cases of children with type1 diabetes, Children under 18 years old
Exclusion criteria: No Parental consent, Non-cooperation until the end of the study (Discontinuation of use)
Intervention groups
Intervention group 1: Includes new cases of type 1 diabetes that hospitalized. In this group, samples (n=21) received insulin Glargine for 3 months. Insulin Glargine was given to the patients once a day, subcutaneous injection and base on of 30-50% of the patient's daily requirement (based on age and clinical response).
Intervention group 2: Includes new cases of type 1 diabetes that hospitalized. In this group, samples (n=2خ) received insulin Detemir for 3 months. Insulin Detemir was given to the patients twice a day, subcutaneous injection and base on of 30-50% of the patient's daily requirement (based on age and clinical response).
Main outcome variables
Rate of Factors affecting appetite (increase/decrease)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045651N1
Registration date:2019-12-23, 1398/10/02
Registration timing:retrospective
Last update:2019-12-23, 1398/10/02
Update count:0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Hosein Momeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
momeni.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-30, 1398/02/10
Expected recruitment end date
2019-08-01, 1398/05/10
Actual recruitment start date
2019-04-30, 1398/02/10
Actual recruitment end date
2019-08-01, 1398/05/10
Trial completion date
2019-08-01, 1398/05/10
Scientific title
Comparison of Insulin Glargine and Detemir on Hormone Factors Affecting Appetite in Patients with Type 1 Diabetes
Public title
Comparison of Insulin Glargine and Detemir on Hormone Factors Affecting Appetite in Patients with Type 1 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parent's Consent
new cases of children with type1 diabetes
Children under 18 years old.
Exclusion criteria:
No Parental consent
Non-cooperation until the end of the study (Discontinuation of use)
Age
From 1 year old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
41
Actual sample size reached:
41
Randomization (investigator's opinion)
Randomized
Randomization description
41 children with new case of diabetes type 1 assigned with simple randomization, according to the table of random number and individual randomization unit. 21 children in the first intervention group (insulin glargine) and 20 (insulin Detemir) neonates in the second intervention group were selected. In this study, do not allocation concealment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Approval date
2019-04-23, 1398/02/03
Ethics committee reference number
IR.IUMS.FMD.REC.1398.052
Health conditions studied
1
Description of health condition studied
Type 1 Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 Diabetes mellitus
Primary outcomes
1
Description
Increase or decrease in Leptin hormone
Timepoint
before taking Insulin and 3 months after taking it
Method of measurement
Laboratory Test (Appetite hormones test)
2
Description
Increase or decrease in Gherlin hormone
Timepoint
before taking Insulin and 3 months after taking it
Method of measurement
Laboratory Test (Appetite hormones test)
3
Description
Increase or decrease in AGRP hormone
Timepoint
before taking Insulin and 3 months after taking it
Method of measurement
Laboratory Test (Appetite hormones test)
4
Description
Increase or decrease in PYY 3-36 hormone
Timepoint
before taking Insulin and 3 months after taking it
Method of measurement
Laboratory Test (Appetite hormones test)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Includes new cases of type 1 diabetes that hospitalized. In this group, samples (n=21) received insulin Glargine for 3 months. Insulin Glargine was given to the patients once a day, subcutaneous injection and base on of 30-50% of the patient's daily requirement (based on age and clinical response).
Category
Treatment - Drugs
2
Description
Intervention group 2: Includes new cases of type 1 diabetes that hospitalized. In this group, samples (n=2خ) received insulin Detemir for 3 months. Insulin Detemir was given to the patients twice a day, subcutaneous injection and base on of 30-50% of the patient's daily requirement (based on age and clinical response).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Children's hospital
Full name of responsible person
Hosein Momeni
Street address
No. 193, Vahid Dastgerdy Ave, Modares Highway, Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
dr.momeni.p@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Shahid Hemmat Highway,Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hosein Momeni
Position
fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6252
Email
momeni.h@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Momeni
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 193, Vahid Dastgerdy Ave, Modares Highway, Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
dr.momeni.p@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Momeni
Position
Fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
dr.momeni.p@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