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The effects of ginger on insulin resistance, lipid profile & lipoproteins in patients with type 2 diabetes

Protocol summary

Summary
This investigation is a randomized controlled clinical trial to determine the effect of ginger on insulin resistance, lipid profiles and lipoproteins in patients with type 2 diabetes The sample size of study is 84 cases.IInclusion criteria: patients with type 2 diabetes ,patients newly diagnosed diabetes to 10 years, no pregnancy and lactation, lack of vitamin and mineral supplementation, without any thyroid , kidney , CVD diseases and not using TG & cholesterol lowering drugs,and also using ESTROGEN or PROGESTRON, FBS<180, 2Hpp<250 . Exclusion criteria: using insulin They are randomly selected. They are assigned to two groups based on random numbers table. patients receive capsules ginger or placebo 3 times a day, 1 gram for 2 months. FBS, ,fasting insulin, cholesterol, triglyceride, LDL and HDL cholesterol and APO-A1,APO-B100, insulin resistance and sensitivity insulin are measured before and after the time of the follow-up.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104246278N1
Registration date: 2011-06-03, 1390/03/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-06-03, 1390/03/13
Registrant information
Name
Behrouz Talaei
Name of organization / entity
Yazd University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
b.talaei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences and Health Services
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-06-21, 1390/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of ginger on insulin resistance, lipid profile & lipoproteins in patients with type 2 diabetes
Public title
The effects of ginger on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with type 2 diabetes ,patients newly diagnosed diabetes to 10 years, no pregnancy and lactation, lack of vitamin and mineral supplementation, without any thyroid , kidney , CVD diseases and not using TG & cholesterol lowering drugs,and also using ESTROGEN or PROGESTRON, FBS<180, 2Hpp<250 . Exclusion criteria: using insulin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
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
University of Medical Sciences and Health Services
Street address
University of Medical Sciences and Health Services-Bahonar sq-YAZD
City
yazd
Postal code
Approval date
2011-03-12, 1389/12/21
Ethics committee reference number
پ/17/1/135711

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Diabetes

Primary outcomes

1

Description
FBS
Timepoint
Before and 2 months after intervention
Method of measurement
mg/dl

2

Description
fasting insulin
Timepoint
Before and 2 months after intervention
Method of measurement
mU/L

3

Description
Fructose amin
Timepoint
Before and 2 months after intervention
Method of measurement
microm/L

4

Description
HbA1C
Timepoint
Before and 2 months after intervention
Method of measurement
%

5

Description
TG
Timepoint
Before and 2 months after intervention
Method of measurement
mg/dl

6

Description
cholesterol
Timepoint
Before and 2 months after intervention
Method of measurement
mg/dl

7

Description
LDL-C
Timepoint
Before and 2 months after intervention
Method of measurement
mg/dl

8

Description
HDL-C
Timepoint
Before and 2 months after intervention
Method of measurement
mg/dl

9

Description
LDL-C/HDL-C
Timepoint
Before and 2 months after intervention
Method of measurement
-

10

Description
APO-A1
Timepoint
Before and 2 months after intervention
Method of measurement
ng/dl

11

Description
APO-B100
Timepoint
Before and 2 months after intervention
Method of measurement
ng/dl

12

Description
insulin resistance, sensitivity
Timepoint
Before and 2 months after intervention
Method of measurement
-

13

Description
-
Timepoint
-
Method of measurement
-

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
control: capsules 1 gr microcristalin cellulose, 3times per day
Category
Treatment - Drugs

2

Description
intervention: capsules ginger 1 gr 3timea per day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Behrouz Talaei Khales soflaei
Street address
jomhuri blv- YAZD
City
yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Medical Sciences and Health Services
Full name of responsible person
Dr Hassan Mozaffari
Street address
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
University of Medical Sciences and Health Services
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
Yazd Diabetes Research Center
Full name of responsible person
Dr Seyed Mohammad Mohammadi
Position
Endocrinologist
Other areas of specialty/work
Street address
Jomhouri blvd, Afshar Hospital Alley,Yazd
City
Yazd
Postal code
Phone
+98 35 1525 8234
Fax
+98 35 1522 3999
Email
mozaffari.kh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Medical Sciences and Health Services
Full name of responsible person
Dr Hassan Mozaffari
Position
PhD, nutritionist
Other areas of specialty/work
Street address
Bahonar sq, Yazd
City
Yazd
Postal code
Phone
+98 35 1724 0171
Fax
+98 35 1724 9333
Email
mozaffari.kh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences and Health Services
Full name of responsible person
Behrouz Talaei Khales Soflaei
Position
MS student of Health Science in Nutrition
Other areas of specialty/work
Street address
Daneshju blvd, Yazd University of Medical Sciences and Health Services ,Yazd
City
Yazd
Postal code
Phone
+98 35 1624 0691
Fax
+98 35 1623 8555
Email
b.talaei@ssu.ac.ir
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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