History
# Registration date Revision Id
1 2017-07-08, 1396/04/17 26489
Changes made to previous revision
This is the first revision

Protocol summary

Summary
This study aimed to compare the effects of honey and sucrose on blood glucose and c-peptide levels in patients with type 1 diabetes. It is a crossover randomized single blind clinical trial. Inclusion criteria: patients with type 1 diabetes mellitus between ages of 2 and 20 on insulin regimen Exclusion Criteria: Steroid therapy,kidney disease, liver disease, endocrine or metabolic disease. 30 patients were randomly divided in 2 groups and were given sucrose and honey solutions interchangeably with a 1 week washout period. After the consumption of each solution, blood glucose levels were assessed with a glucometer in 0, 30, 60, 90, 120, 180 minutes. Blood samples were obtained in 0 and 120 min intervals to assess c-peptide levels.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017062834783N1
Registration date: 2017-07-08, 1396/04/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-08, 1396/04/17
Registrant information
Name
Sara Sedaghat
Name of organization / entity
Gabric Diabetes Association
Country
Iran (Islamic Republic of)
Phone
+98 21 8243 3000
Email address
s.sedaghat@gabric.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of honey and sucrose on blood glucose and C-peptide in patients with type 1 diabetes mellitus
Public title
Effect of honey on blood glucose
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: patients with type 1 diabetes mellitus; ages of 2 and 20; treated by insulin regimen Exclusion Criteria: Steroid therapy; kidney disease; liver disease; endocrine or metabolic disease
Age
From 2 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Randomization was performed using "random numbers table" and patients were divided in two groups. Blinding was also performed on patients, as neither of the groups were aware of the content of their given solutions.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Medical school, Iran University of Medical sciences, Hemmat Expway.
City
Tehran
Postal code
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.IUMS.FMD.Rec 1396.8721215021

Health conditions studied

1

Description of health condition studied
Type 1 diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Blood Glucose
Timepoint
0,30,60,90,120,180
Method of measurement
Glucometry with Glucocard-01 glucometer

2

Description
C-Peptide
Timepoint
0 and 120 min
Method of measurement
Venous blood sample for C-peptide measurement using ELISA laboratory kits

Secondary outcomes

empty

Intervention groups

1

Description
Honey solution: the amount of honey solution is calculated based on each patients weight, using Nelson's textbook of pediatrics table named "Total daily calorie requirements based on weight"
Category
Other

2

Description
Sucrose solution: the amount of sucrose solution is calculated based on each patients weight, using Nelson's textbook of pediatrics table named "Total daily calorie requirements based on weight". Sucrose solution is prepared by adding sugar to drinking water
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Gabric Diabetes Education Association
Full name of responsible person
Sara Sedaghat
Street address
No 4, 16th St., Vozara St., Argentina Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Zhila Cheshmi
Street address
Medical faculty, Iran University of Medical Sciences, Hemmat expway.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gabric Diabetes Association
Full name of responsible person
Sara Sedaghat
Position
Head of Science Department
Other areas of specialty/work
Street address
No 4, 16th St., Vozara St., Argentina Sq.
City
Tehran
Postal code
Phone
+98 21 8243 3000
Fax
Email
s.sedaghat@gabric.ir; s.sedaghat68@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fahimeh Soheilipour
Position
Pediatric Endocrinologist
Other areas of specialty/work
Street address
Minimally invasive surgeries research center, Rasool Akram general hospital, Niayesh St, Sattarkhan St
City
Tehran
Postal code
Phone
+98 21 6653 5448
Fax
Email
fsoheilipour@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gabric Diabetes Education Association
Full name of responsible person
Sara Sedaghat
Position
Other areas of specialty/work
Street address
No.4 , 16th St., Vozara St., Argentina Sq.
City
Tehran
Postal code
Phone
+98 21 8243 3000
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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