The effect of propolis tablet on glycemic control, lipid profile and insulin resistance in comparison with placebo in patients with type 2 diabetes mellitus
In this double-blind placebo controlled clinical trial, 67 volunteers (with considering 10% loss) who have diabetes type 2 will participate by random. Participants will be divided into 2 groups, intervention and control. we will request from the intervention group to use three tablets of propolis and the control group to use three tablets of placebo daily. Before and after the intervention, biochemical tests such as LDL, HDL, TG, Total Chol, FBS, HbA1c and Insulin will be measured. The height, weight and 24-hour dietary recalls will be measured too. Participants will be asked not to change their physical activity, diet and life style during the intervention. we will follow them by phone calls or visits. The intervention duration will be 12 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080218659N1
Registration date:2015-09-07, 1394/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-07, 1394/06/16
Registrant information
Name
Nazli Samadi Bilehsavar
Name of organization / entity
Shahid Sadooghi University of Medical Sciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 35362406915
Email address
nazlisamadi510@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University Medical Sciences and Health Services
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of propolis tablet on glycemic control, lipid profile and insulin resistance in comparison with placebo in patients with type 2 diabetes mellitus
Public title
Effect of propolis on diabetes mellitus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with type 2 diabetes mellitus, diagnosed 5-10 years ago, under treatment with oral hypoglycemic agents.
Exclusion criteria: pregnancy, lactation, insulin therapy, any other diseases such as autoimmune, intestinal, liver, thyroid and cardiovascular diseases, vitamin and mineral supplementation, history of dermal or digestive hypersensitivity to propolis, any severe respiratory disease (such as asthma, chronic bronchitis), report of side effects of propolis tablets.
Age
From 25 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
67
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
A double blind study. Patients and researcher are blind about intervention and placebo groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Shahid Sadoghi University of Medical Sciences Ethics Committee
Street address
University of Medical Sciences and Health Services-Bahonar sq-YAZD
City
Yazd
Postal code
Approval date
2014-11-26, 1393/09/05
Ethics committee reference number
17/1/179454/پ
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Glucose
Timepoint
Before and after intervention
Method of measurement
Enzymatic method (mg/dl)
2
Description
Fasting insulin
Timepoint
Before and after intervention
Method of measurement
ELISA(mU/l)
3
Description
Triglyceride
Timepoint
Before and after intervention
Method of measurement
Enzymatic method (mg/dl)
4
Description
Total cholesterol
Timepoint
Before and after intervention
Method of measurement
Enzymatic method (mg/dl)
5
Description
LDL-C
Timepoint
before and after intervention
Method of measurement
Friedewald formula (mg/dl)
6
Description
HDL-C
Timepoint
before and after intervention
Method of measurement
Precipitation(mg/dl)
7
Description
Insulin resistance, sensitivity
Timepoint
Before and after intervention
Method of measurement
Software
Secondary outcomes
1
Description
HA1C
Timepoint
The baseline and three months after the intervention
Method of measurement
Turbidometry
Intervention groups
1
Description
Patients in intervention group receive propolis tabletes,3 times a day, for 12 weeks.Each tablet contains 300 mg propolis.
Category
Treatment - Drugs
2
Description
Patients in control group, receive placebo tablets 3 times a day for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Masoud Rahmanian, Assistant Professor of Endocrinology
Street address
Diabetes Center, Honar Alley, Bahonar Sq
City
Yazd
2
Recruitment center
Name of recruitment center
Emam Ali Clinic
Full name of responsible person
Masoud Rahmanian, Assistant Professor of Endocrinology
Street address
Dolat Abad Crossroad
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amirhooshang Mehrparvar
Street address
Vice Chancellor for Research,Yazd University of Medical Sciences,Bahonar.Sq,yazd
City
Yazd
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, Yazd Shahid Sadoughi 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
Shahid Sadooghi University of Medical Sciences and Health
Full name of responsible person
Nazli Samadi Bilehsavar
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Health, Imam Reza building, Student Blvd, Imam Hossein Square
City
Yazd
Postal code
89165887
Phone
+98 35 3624 0691
Fax
+98 36238555
Email
nazlisamadi510@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences and Health Services in Yazd
Full name of responsible person
Hassan Mozaffari Khosravi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Department of Health, Imam Reza building, Student Blvd, Imam Hossein Square
City
Yazd
Postal code
89165887
Phone
+98 35 3624 0691
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences and Health
Full name of responsible person
Nazli Samadi Bilehsavar
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Health, Imam Reza Building, Student Blvd, Imam Hossein Square
City
Yazd
Postal code
89165887
Phone
+98 35362406915
Fax
Email
nazlisamadi510@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)