Find alternatives to improve glycemic index status instead of metformin
Design
In this study, designing the Zelen design, individuals will be randomly assigned into two groups of control and intervention and then informed consent will be obtained. They know and people in the control group know that they use routine treatment. Patients do not become blind to the drug they receive
Settings and conduct
Patients referred to Sanandaj Endocrinology Clinic aged 15 to 25 years were studied according to inclusion and exclusion criteria, divided by random numbers into test and control groups, and obtaining informed consent from patients and parents with Zelen's design without blinding design. .
At the beginning of the study, the demographic variables of fasting blood sugar and insulin and HOMA index are measured. Three months after taking treatment, fasting insulin and blood sugar levels and HOMA index are measured again.
Ready packs containing herbal capsules for one group and metformin for the other group were given to patients. The capsule was instructed that the research unit should consume one capsule daily after lunch. Patients should be referred if they have any side effects.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Overweight and obesity
Exclusion criteria:
lack of kidney or liver disease
Do not take drugs such as corticosteroids that cause elevated glucose levels.
Other medicines to control blood sugar,
Type 2 diabetes based on fasting blood sugar, HbA1C criteria and clinical symptoms
Intervention groups
Obese or overweight patients aged 15 to 25 years in two groups receiving metformin and group receiving glucohydrate
Evaluation of the effect of Glucoherb (herbal drug) in comparison with metformin on decreasing insulin resistance in prediabetic children with obesity
Public title
Effect of Glucoherb (herbal drug) in comparison with metformin on decreasing insulin resistance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight
Obesity
Lack of Documented Diabetes
Exclusion criteria:
Documented Diabetes
Taking affect glucose level drugs like corticosteroids
Liver disorders
kidney disorders
Use other blood glucose control drugs
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals were randomly assigned to test and control groups based on the random numbers obtained from the randomized Excel program.
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 Kurdistan University of Medical Sciences
Street address
pasdaran Blvd, opposite Shadi Hotel, Kurdistan University of Medical Sciences, Sanandaj, Management of Medical Researches and Information. POB 6617713446
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.MUK.REC.1398.189
Health conditions studied
1
Description of health condition studied
Obesity and Overweight
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Fasting blood Glucose level
Timepoint
Start and end of the study
Method of measurement
Enzymatic method of hexokinase
2
Description
Glycosylated hemoglobin
Timepoint
Start and end of the study
Method of measurement
HPLC method
3
Description
Insulin Resistance index
Timepoint
Start and end of the study
Method of measurement
Using the HOMA Index formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Daily one Glucoherb Capsule
Category
Treatment - Drugs
2
Description
Control group: Daily 500 mg Metformin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Asadollah Fathollah pour
Street address
Vakil Crossroad, Besat Hospital, Department of pediatrric
City
Sanandaj
Province
Kurdistan
Postal code
000000000000
Phone
+98 87 3328 2004
Email
fatholapour@yahoo.com
2
Recruitment center
Name of recruitment center
Asadollah Fathollah pour office
Full name of responsible person
Asadollah Fathollah pour
Street address
Mehr Doctors Building, Yagmoori Alley, Pasdaran Blve
City
Sanandaj
Province
Kurdistan
Postal code
000000000000
Phone
+98 87 3328 2314
Email
fatholapour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Sanandaj, Kurdistan University of Medical Sciences, opposite Shadi Hotel, Kurdistan University of Medical Science, POB 6617713446 Management of medical research and information
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Pediatric Residency program
Grant code / Reference number
IR.MUK.REC.1398.189
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Mohsen Akheshteh
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
pasdaran Blvd, opposite Shadi Hotel, Kurdistan University of Medical Sciences, Sanandaj, Management of Medical Researches and Information. POB 6617713446
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
khalafi.behzad70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Asadollah Fathollah Pour
Position
Assosciated professor of Pediatric Endocrinology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Department of Pediatrics, Besat Hospital, Vakil Crossroad , Sanandaj
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3328 2004
Email
fatholapour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Associate / Researcher Soldier - General Physician of Kurdistan University of Medical Scien
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kurdistan University of Medical Sciences Vice Chancellor in Research Affair Pasdaran Ave. Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 45 3344 9697
Fax
+98 87 3366 4645
Email
khalafi.behzad70@muk.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is from the proposal, raw data and project reports
When the data will become available and for how long
داده ها 6 ماه پس از انتشار به مدت دو سال قابلیت دسترسی از طریق تقاضا از سیستم قانونی را دارد
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
Asadollah Fathollah pour
What processes are involved for a request to access data/document
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given.