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Survey of oral propolis effect on antioxidant status, lipid peroxidation, lipid profiles, Insulin resistance, blood glucose and glycosylated hemoglobin in patients with type 2 diabetes: A double-blind placebo-controlled clinical trial

Protocol summary

Summary
The aim of this randomized, placebo-controlled trial is to investigate the effects of propolis supplementation on some blood biochemical parameters in people with type II diabetes. Sixty patients with type II diabetes are of both sexes to participate in the study. Eligible patients will randomly be divided into two groups using a table of random numbers. Participants in the intervention group received three capsules of 500 mg of propolis for two months and the control group received placebo. Fasting blood glucose, lipid profile,oxidized LDL, fructosamine, glycosylated hemoglobin, insulin, insulin resistance, antioxidant capacity, glutathione peroxidase, dismutase (SOD),Catalase, inflammatory markers TNFα and CRP, interleukin 6 and 17 and liver enzymes aspartate aminotransferase and alanine aminotransferase in two groups before the intervention and at the end of the study measured and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041019669N4
Registration date: 2017-05-20, 1396/02/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Qazvin University of Medical Science
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of oral propolis effect on antioxidant status, lipid peroxidation, lipid profiles, Insulin resistance, blood glucose and glycosylated hemoglobin in patients with type 2 diabetes: A double-blind placebo-controlled clinical trial
Public title
Survey of oral propolis effect in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having the type 2 diabetes -voluntary consent for participation in the study Exclusion criteria: -use of multivitamin-mineral supplements at least 6month before the study -smoking, alcohol abuse -treatment with insulin -having the hepatic, renal failure, cardiovascular, celiac, gastrointestinal, rheumatic
Age
From 30 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the researcher and patient to the drug and placebo are blind, so this is a double-blind study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Approval date
2017-02-27, 1395/12/09
Ethics committee reference number
IR.QUMS.REC.1395.294

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 Sugar
Timepoint
Before intervention and two months after intervention
Method of measurement
ELISA

2

Description
Insulin
Timepoint
Before intervention and two months after intervention
Method of measurement
ELISA

3

Description
HbA1c
Timepoint
Before intervention and two months after intervention
Method of measurement
ELISA

4

Description
Lipid profile
Timepoint
Before intervention and two months after intervention
Method of measurement
ELISA

5

Description
Added at 2017-10-28: Fructosamine
Timepoint
Added at 2017-10-28: Before intervention and 2 month after intervention
Method of measurement
Added at 2017-10-28: Eliza

Secondary outcomes

1

Description
Antioxidant indices
Timepoint
Before intervention and two months after intervention
Method of measurement
ELISA

2

Description
Added at 2017-10-28: Inflammatory factors
Timepoint
Added at 2017-10-28: Before intervention and 2 month after intervention
Method of measurement
Added at 2017-10-28: Eliza

Intervention groups

1

Description
Control group: placebo weight flour supplementation, 1.5 gr daily, three capsoles for 2 months
Category
Placebo

2

Description
Intervention group: Propolis capsules, 1500 mg daily, three capsules of 500 mg, for two months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Street address
Velayat Hospital, Qazvin
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
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, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Position
Nutrition Ph.D
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3732 7650
Fax
Email
khademnut@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Position
Assistant Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3732 7650
Fax
Email
khademnut@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Position
Assistant Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3732 7650
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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