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The effect of ginger on glycemic status, apolipoprotein B, apolipoprotein A-I, total antioxidant capacity (TAC), malondialdehyde (MDA), high sensitivity c-reactive protein (hsCRP), and paraoxonase in type 2 diabetic patients

Protocol summary

Summary
This study examined The effect of ginger on glycemic status, apolipoprotein B, apolipoprotein A-I, total antioxidant capacity (TAC), malondialdehyde (MDA), high sensitivity c-reactive protein (hsCRP), and paraoxonase in type 2 diabetic patians.In this placebo-controlled double-blind randomized clinical trial, 70 patients with diabetes who qualify and are enrolled into the study.Patients in case group are receiving about 3 grams of powdered ginger daily for 3 months and control patients are receiving 3 glactose powder daily for 3 months.After the 3-month intervention period, glycemic status, apolipoprotein B, apolipoprotein A-I, total antioxidant capacity (TAC), malondialdehyde (MDA), high sensitivity c-reactive protein (hsCRP), and paraoxonase 2 groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109082709N19
Registration date: 2011-10-07, 1390/07/15
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-10-07, 1390/07/15
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginger on glycemic status, apolipoprotein B, apolipoprotein A-I, total antioxidant capacity (TAC), malondialdehyde (MDA), high sensitivity c-reactive protein (hsCRP), and paraoxonase in type 2 diabetic patients
Public title
The effect of ginger on glycemic status, apolipoprotein B, apolipoprotein A-I, total antioxidant capacity (TAC), malondialdehyde (MDA), high sensitivity c-reactive protein (hsCRP), and paraoxonase in type 2 diabetic patiants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Non-insulin dependent diabetic patients with type 2 diabetes that is diagnosed by a physician, Endocrinologist.Diabetes duration of at least 2 years , 20-60 ages,Hb A1c :6-8% , Lack of antioxidant supplements such as selenium, zinc, beta carotene, and ... At least 3 months before the study - not smoking, and alcohol - a willingness to cooperate with exclusion criteria: Patient unwillingness to continue with the plan - changes in type or dose of medication, Changes in diet or physical activity every day - taking any antioxidant supplements - taking less than 80% of supplements given to patients at baseline(the compaliance lower than %80),Recent receive insulin - pregnancy and lactation - renal , hepatic , thyroid diseases and anemia - hypersensitivity to the drug
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Vive-chancellor for Research, Tehran University of Medical Sciences
Street address
Keshavarz Bld - intersection of Qods street
City
Tehran
Postal code
Approval date
2011-07-12, 1390/04/21
Ethics committee reference number
132/1287

Health conditions studied

1

Description of health condition studied
type 2 diabetese melitus
ICD-10 code
E11
ICD-10 code description
R81

Primary outcomes

1

Description
fasting blood sugar
Timepoint
before & after intervention (3 months later)
Method of measurement
glucose oxidase method

2

Description
Hb A1C
Timepoint
before & after intervention (3 months later)
Method of measurement
colorimetry

3

Description
insulin
Timepoint
before & after intervention (3 months later)
Method of measurement
IRMA

4

Description
insulin resistance
Timepoint
before & after intervention (3 months later)
Method of measurement
insulin × glucose / 22.5

5

Description
Apo A
Timepoint
before & after intervention (3 months later)
Method of measurement
immunotorbidometry

6

Description
Apo B
Timepoint
before & after intervention (3 months later)
Method of measurement
immunotorbidometry

7

Description
Apo B/Apo A-I
Timepoint
before & after intervention (3 months later)
Method of measurement
ratio

8

Description
high-sensitivity C-Reactive Protein
Timepoint
before & after intervention (3 months later)
Method of measurement
ELISA kitt

9

Description
total antioxidant capacity
Timepoint
before & after intervention (3 months later)
Method of measurement
colorimetry (FRAP)

10

Description
malondealdehyde
Timepoint
before & after intervention (3 months later)
Method of measurement
colorimetry

11

Description
paraoxonase
Timepoint
before & after intervention (3 months later)
Method of measurement
colorimetry

Secondary outcomes

empty

Intervention groups

1

Description
intervention group : ginger supplement, 3 gram per day and during 3 months
Category
Treatment - Drugs

2

Description
control group : lactose supplement, 2 grams per day and during 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Diabetes Association
Full name of responsible person
Dr Asaddollah Rajab
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vive-chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Seyyed Abbas Motevalian
Street address
Keshavarz Bld - intersection of Qods street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vive-chancellor for Research, Tehran 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
School of Public Health of Tehran University of Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
Professor Assistant/nutrition PhD
Other areas of specialty/work
Street address
Argentina square, the end of Alvand street, number 60
City
Tehran
Postal code
1516846515
Phone
+98 21 8877 9118
Fax
+98 21 8877 9487
Email
farzadshidfar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health of Tehran University of Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
Professor Assistant/nutrition PhD
Other areas of specialty/work
Street address
Argentina square, the end of Alvand street, number 60
City
Tehran
Postal code
1516846515
Phone
+98 21 8877 9118
Fax
+98 21 8877 9487
Email
farzadshidfar@yahoo.com
Web page address

Person responsible for updating data

Contact

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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