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Effect of resveratrol in cotrolling the fasting blood glucose in patients with type 2 DM

Protocol summary

Summary
In recent years, most of the researchers from all over the world have been trying to use the extracts of herbal medicines and also the antioxidants from the fruits, to prevent the effects of oxidants and also to replace the chemical drugs with these natural medicines. Resveratrol (trihydrostilbeen-3, 5, 4), which is a polyphinol, has been one of the main topic of the researchers, for past decay. Sixty six patients having type 2 DM, were divided into two groups ( 33, having resveratrol,500 mg,twice daily, morning and evening for 45 days)The 2nd group (33, having the placebo , inert micro cellulose)The parameters including,HbA1c, FBS, Insulin, lipids, lipoproteins and liver enzymes will be measured before and after the prevention. Demographic data and general health characteristics including height, social habit, smoking status, and also Blood pressure, BMI, duration of the disease, morbidity will be registered by using a standard questionnaire for each patient. Finally, the results will be analyzed by Simple, paired t-test, Repeated measurement and the significant value will be presented as <0.05

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111198129N1
Registration date: 2012-11-11, 1391/08/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-11, 1391/08/21
Registrant information
Name
Ali Movahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 4044
Email address
a.movahed@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2012-10-01, 1391/07/10
Expected recruitment end date
2013-01-29, 1391/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of resveratrol in cotrolling the fasting blood glucose in patients with type 2 DM
Public title
Effect of Resveratrol in controlling blood glucose in type 2 Diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Iinclusion Criteria: Patients with T2DM; subjects with good peripheral vain; patients on oral hypoglycemic treatment (met.formine.and/or glibenclamid) as long as they are on stable doses and the dosage is not changed during the course of the study. Exclusion Criteria: Subjects on any antioxidant therapy such as vitamin supplements ; having allergy to grapes,green tea and peanuts; patients with type 1 diabetes; pregnant women ; lactating mothers; severe heart disease ; hepatic disease ; renal dysfunction ; smoking.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
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
Bushehr University of Medical Sciences
Street address
Pardis Site, Next to Salmon Farsi Hospital ,Bushehr University of Medical Sciences, Bushehr,Iran.
City
Bushehr
Postal code
Approval date
2011-09-19, 1390/06/28
Ethics committee reference number
B-90-12-4

Health conditions studied

1

Description of health condition studied
Non- Insulin Dependent Diabetes mellitus
ICD-10 code
E 14
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
HbA1c
Timepoint
Before the intervention and 45 days after intervention, three months after the end of the intervention
Method of measurement
boronate affinity assay kit (Nycocard HbA1c, Axis- SHIELD poc AS, Norway)

2

Description
Insuline
Timepoint
Before the intervention and 45 days after intervention, three months after the end of the intervention
Method of measurement
electrochemiluminescence immunoassay "ECLIA" kit, (Elecsys and Cobbas, Roche Diagnostics Gmbh, Sandhofer strasse 116, D – 68305 mannheim

3

Description
FBS
Timepoint
Before the intervention and 45 days after intervention, three months after the end of the intervention
Method of measurement
by enzymatic method

Secondary outcomes

1

Description
cholestrol
Timepoint
before the intervention and after 45 days of intervention
Method of measurement
by enzymatic method,in mg/dl

2

Description
triglyceride
Timepoint
before the intervention and after 45 days of intervention
Method of measurement
by enzymatic method,in mg/dl

3

Description
HDL-cholestrole
Timepoint
before the intervention and after 45 days of intervention
Method of measurement
by enzymatic method,in mg/dl

4

Description
LDL-cholestrole
Timepoint
before the intervention and after 45 days of intervention
Method of measurement
by enzymatic method,in mg/dl

5

Description
Blood pressure
Timepoint
before the intervention and after 45 days of intervention
Method of measurement
using a standard mercury sphygmomanometer

Intervention groups

1

Description
Intervention group(500 mg / twice daily of Resveratrol capsules ); morning and evening; consumed orally and for a period of 45 days.
Category
Treatment - Drugs

2

Description
Intervention group(500 mg / twice daily of Plasibo capsules ); morning and evening; consumed orally and for a period of 45 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Street address
Biochemistry Lab Faculty of Medicine, Bushe hr University of Medical Sciences, Bushehr,Iran.
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Research, Bushehr University of Medical Sciences
Full name of responsible person
Dr Ostovar
Street address
Pardis Site, Next to Salmon Farsi Hospital, Department of Research,Bushehr University of Medical Science
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Research, Bushehr 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
Bushehr university of medical sciences
Full name of responsible person
Ali Movahed
Position
Ph.D Head of dept of Biochemistry
Other areas of specialty/work
Street address
Bushehr university of medical sciences
City
Bushehr
Postal code
00987712529198
Phone
+98 77 1252 9198
Fax
Email
amirali_1957@yahoo.comamovahed58@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Position
Ph.D,Head of Depart of clinical Biochemistry
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences.Faculty of Medicine,Biochemistry Lab
City
Bushehr
Postal code
751473537
Phone
00987712529198 00987712529198
Fax
Email
amirali_1957@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr university of medical sciences
Full name of responsible person
Ali Movahed
Position
Ph.D head of dept of Biochemistry
Other areas of specialty/work
Street address
Bushehr university of medical sciences,Faculty of medicine,Biochemistry Lab
City
Bushehr
Postal code
751473537
Phone
+98 77 1252 9198
Fax
+98 987712520657
Email
amirali_1957@yahoo.com
Web page address
www.bpums.ac.ir

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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