Evaluation and comparison of the effect of Cinnamon and Chromium Picolinate supplementation on Hemoglobin A1c in Patients with Type 1 Diabetes mellitus.
Finding a treatment to reduce hemoglobin A1C and increase the quality of life of patients with type 1 diabetes mellitus by reducing the insulin consumption.
Design
This study was conducted as a clinical trial with two intervention groups and one control group, parallel, double-blind, randomized on 90 patients.
Settings and conduct
This study was a double-blind, randomized controlled clinical trial which was conducted on patients with type 1 diabetes who were younger than 18 years old referring to Mofid Hospital clinic in 1400.
The samples were randomly assigned to three groups receiving cinnamon, chromium picolinate and control group. Researchers and patients were blinded to the contents of the boxes.
Participants/Inclusion and exclusion criteria
Entry conditions:
Type 1 diabetes has been diagnosed for 18 months before entering the study.
Being less than 18 years old when entering the study.
Not being allergic to supplements.
Non-entry conditions:
No history of medical or psychiatric hospitalization in the last 12 months.
Pregnancy or breastfeeding.
Hemoglobinopathy.
Acute infections (pneumonia, urinary tract infection, otitis).
Intervention groups
The first group: 180 capsules each contains 500 mg cinnamon in Synabetic brand used twice daily.
The secondgroup: 90 tablets each contains 200 mcg chromium picolinate of VITABIOTICS brand used once daily.
Control group:No intervention and no placebo, just used their routine insulin regime and followed in the same period.
These steps were repeated in two 90 days courses and they received supplements for 180 days in total.
Main outcome variables
Body Mass Index; Duration of diagnosis; Fasting Blood Sugar; Hemoglobin A1C; TYG index; Insulin Carbohydrate Ratio; Daily Use of Insulin.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230501058037N1
Registration date:2023-06-19, 1402/03/29
Registration timing:retrospective
Last update:2023-06-19, 1402/03/29
Update count:0
Registration date
2023-06-19, 1402/03/29
Registrant information
Name
Shirin Ghane fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2238 9479
Email address
sh.ghanefard@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
2022-05-21, 1401/02/31
Actual recruitment end date
2023-04-20, 1402/01/31
Trial completion date
2023-07-22, 1402/04/31
Scientific title
Evaluation and comparison of the effect of Cinnamon and Chromium Picolinate supplementation on Hemoglobin A1c in Patients with Type 1 Diabetes mellitus.
Public title
Effect of Cinnamon and Chromium Picolinate supplementation on Hemoglobin A1c in Patients with Type 1 Diabetes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 diabetes has been diagnosed for 18 months before entering the study
Patients must be less than 18 years old when entering the study
Refer to Mofid hospital clinic for routine care
Patients have not taken medicinal plants or other supplements in the last 8 weeks
Do not be allergic to supplements
Exclusion criteria:
Patients do not have a history of hospitalization for medical or psychiatric reasons in the last 12 months
It is not possible to access by phone
Pregnancy or breastfeeding
Hemoglobinopathy
Acute infection (pneumonia, urinary tract infection, otitis)
Age
To 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Due to randomization of participants of this study, we used restricted randomization in type of block randomiztion.Size of blocks were equal and consisted of six participants, two participants in cinnamon, two participants in chromium picolinate and two in control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Cinnamon and Chromium Picolinate were placed in boxes that could not be distinguished by Color, Size and Shape.Researchers and Participants were blinded to the contents of the boxes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo boulevard, Velenjak street.
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2021-11-22, 1400/09/01
Ethics committee reference number
IR.SBMU.MSP.REC.1400.572
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10.9
ICD-10 code description
Type 1 diabetes mellitus without complications
Primary outcomes
1
Description
Age Of The Patient
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
2
Description
Gender Of The Patient
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
3
Description
Height Of The Patient
Timepoint
At The Beginning Of The Study
Method of measurement
Meter
4
Description
Patient Weight
Timepoint
At The Beginning Of The Study
Method of measurement
Scales
5
Description
Body Mass Index
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
6
Description
Duration of diagnosis
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
7
Description
The Stage Of Maturation Of The Patient
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
8
Description
Fasting Blood Sugar
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic – Laboratory
9
Description
Hemoglobin A1C
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic – Laboratory
10
Description
Triglyceride
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic – Laboratory
11
Description
TYG index
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic – Laboratory
12
Description
Insulin Carbohydrate Ratio
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic – Laboratory
13
Description
Daily Use of Insulin
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Questionnaire-Clinical File
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: 180 capsules containing 500 mg cinnamon of Synabetic brand for using 2 times per day were provided to each patient in two 90 days courses, and the patients received supplements for 180 days in total.
Category
Treatment - Drugs
2
Description
The second intervention group: 90 tablets containing 200 microgram of chromium picolinate in VITABIOTICS brand for using once daily was provided to patients in two 90 days courses and the patients received supplements for 180 days in total.
Category
Treatment - Drugs
3
Description
Control group: With no intervention or placebo consumption and just with their insulin regime, control group were followed and evaluated the same as interventional groups in two 90 days courses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children's Hospital
Full name of responsible person
Shirin Ghane Fard
Street address
Mofid Children's Hospital, Dr Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
info-mch@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo boulevard, Velenjak street.
City
Tehran
Province
Tehran
Postal code
9411983961
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shirin Ghane Fard
Position
Consulltant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mofid Children's Hospital, Dr Shariati street
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
Sh.ghanefard@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadab Salehpour
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Loghman-e Hakim Hospital, Kamali street, Karegar Ave.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
shadab.salehpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shirin Ghane Fard
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mofid Children's Hospital, Dr Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
Sh.ghanefard@sbmu.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
Data can potentially be shared after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions and people working in industry