Comparative study of the effects of cinnamon and whortleberry for decreasing fasting blood sugar and HbA1c in patients with type 2 diabetes in Karaj city
The aim of this study is to compare the effects of cinnamon and whortleberry on reduction of Hb A1C and fasting blood sugar in patients with type II of diabetes. This is a randomized, double-blind, placebo controlled, multi-center trial with three groups. A total of 90 diabetic patients with fasting blood sugar more than or equal to 126 mg/dl and Hb A1C more than 6 percent who have no underlying disease, will be randomly allocated into the following three groups. The patients in the intervention groups will be treated with cinnamon or whortleberry, two 500 mg capsules per day after breakfast and lunch for three months. The patients in the control group will receive two 500 mg starch capsules per day after breakfast and lunch for three months. Body mass index (BMI), serum concentrations of fasting blood sugar, Hb A1C, and serum level of insulin will be checked before and three months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905132892N2
Registration date:2011-04-07, 1390/01/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-07, 1390/01/18
Registrant information
Name
Mani Mirfeizi
Name of organization / entity
Islamic Azad University Karaj branch
Country
Iran (Islamic Republic of)
Phone
00982614403254/ 00982614182580/ 00982614455635
Email address
mani@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University of Karaj branch
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effects of cinnamon and whortleberry for decreasing fasting blood sugar and HbA1c in patients with type 2 diabetes in Karaj city
Public title
The effects of cinnamon and whortleberry for treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic patients with fasting blood sugar more than or equal to 126 mg/dl, Hb A1C above 6 percent, not having any underlying disease, treating with oral hypoglycemic drugs
Exclusion criteria: Presence of underlying disease like as renal, connective tissue, cardiac, thyroid, or adrenal diseases, Following an especial type of diet or doing exercise; receiving insulin or taking cinnamon or whortleberry supplemental products; Smoking, drinking alcohol; pregnancy, lactation
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Islamic Azad university of Karaj branch
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Mailbox: 31485-313
City
Karaj
Postal code
Approval date
2010-08-15, 1389/05/24
Ethics committee reference number
001
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type II
ICD-10 code
E10-E14
ICD-10 code description
Primary outcomes
1
Description
Serum fassting blood sugar
Timepoint
Before intervention, one and half and three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits
2
Description
Serum Hb A1C
Timepoint
Before intervention and three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits
Secondary outcomes
1
Description
Serum insulin
Timepoint
Before intervention and three months after intervention
Method of measurement
Serological test with Electro Komolomynsans method with using of the company's ROCHE kits
2
Description
Body mass index
Timepoint
Before intervention, one and half and three months after intervention
Method of measurement
According to kg/m2 with using standard meter and scale
Intervention groups
1
Description
For control group: Two 500 mg starch capsules per day after breakfast and lunch for three months
Category
Placebo
2
Description
For second intervention group: Two 500 mg whortleberry capsules per day after breakfast and lunch for three months
Category
Treatment - Drugs
3
Description
For first intervention group: Two 500 mg cinnamon capsules per day after breakfast and lunch for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Dr. Mani Mirfeizi
Full name of responsible person
Dr. Mani Mirfeizi
Street address
Omid physician building, Beheshti Avenue, Karaj
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University of Karaj branch
Full name of responsible person
Dr. Abas Ahmadi
Street address
Vice chancellor for research, Islamic Azad University of Karaj branch, Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj
City
Karaj
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, Islamic Azad University of Karaj branch
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
Islamic Azad University Karaj branch
Full name of responsible person
Dr. Mani Mirfeizi
Position
Professor of Internal medicine / Dean of Nursing and Midwifery Karaj branch
Other areas of specialty/work
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Nursing & midwifery faculty
City
Karaj
Postal code
Phone
00982614403254; 00982614182580; 00982614455635
Fax
Email
Mani@kiau.ac.ir; Manimirfeizi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Karaj branch
Full name of responsible person
Dr. Mani Mirfeizi
Position
Professor of Internal medicine / Dean of Nursing and Midwifery Karaj branch
Other areas of specialty/work
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Nursing & midwifery faculty
City
Karaj
Postal code
Phone
00982614403254; 00982614182580; 00982614455635
Fax
Email
Man@kiau.ac.ir; Manimirfeizi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Karaj branch
Full name of responsible person
Zahra Mehdizadeh Toorzani
Position
Master of midwifery
Other areas of specialty/work
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Nursing & midwifery faculty
City
Karaj
Postal code
Phone
+98 21 3372 5785
Fax
Email
Zahramehdizade@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)