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Effect of resveratrol in cotrolling the fasting blood glucose in patients with type 2 DM
Acronym :
IRCT registration number : Irct registration number : IRCT201111198129N1
Date registered : November 11, 2012
Registration timing : Registration while recruiting
   
Recruitment status : Recruitment complete
Expected recruitment start date : 2012-10-01
Expected recruitment end date : 2013-01-29
   
Scientific title : Effect of resveratrol in cotrolling the fasting blood glucose in patients with type 2 DM
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

   
Public title : Effect of Resveratrol in controlling blood glucose in type 2 Diabetic patients
Purpose : Supportive care
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.
Minimum age : Year: 20         
Maximum age : Year: 65         
Gender : Both male and female
   
Health condition table is empty1 : Non- Insulin Dependent Diabetes mellitus
Condition studied : E 14
Condition ICD-10 code : Non-insulin-dependent diabetes mellitus
   
Intervention/Control1 Intervention group(500 mg / twice daily of Resveratrol capsules ); morning and evening; consumed orally and for a period of 45 days.
Intervention category Treatment: drugs
Intervention/Control2 Intervention group(500 mg / twice daily of Plasibo capsules ); morning and evening; consumed orally and for a period of 45 days.
Intervention category Treatment: drugs
   
Primary outcome measure1: FBS
Primary outcome time point Before the intervention and 45 days after intervention, three months after the end of the intervention
Primary outcome method of measurement by enzymatic method
Primary outcome measure2: HbA1c
Primary outcome time point Before the intervention and 45 days after intervention, three months after the end of the intervention
Primary outcome method of measurement boronate affinity assay kit (Nycocard HbA1c, Axis- SHIELD poc AS, Norway)
Primary outcome measure3: Insuline
Primary outcome time point Before the intervention and 45 days after intervention, three months after the end of the intervention
Primary outcome method of measurement electrochemiluminescence immunoassay "ECLIA" kit, (Elecsys and Cobbas, Roche Diagnostics Gmbh, Sandhofer strasse 116, D – 68305 mannheim
   
Secondary outcome measure 1 : cholestrol
Secondary outcome time point before the intervention and after 45 days of intervention
Secondary outcome method of measurement by enzymatic method,in mg/dl
Secondary outcome measure 2 : triglyceride
Secondary outcome time point before the intervention and after 45 days of intervention
Secondary outcome method of measurement by enzymatic method,in mg/dl
Secondary outcome measure 3 : HDL-cholestrole
Secondary outcome time point before the intervention and after 45 days of intervention
Secondary outcome method of measurement by enzymatic method,in mg/dl
Secondary outcome measure 4 : LDL-cholestrole
Secondary outcome time point before the intervention and after 45 days of intervention
Secondary outcome method of measurement by enzymatic method,in mg/dl
Secondary outcome measure 5 : Blood pressure
Secondary outcome time point before the intervention and after 45 days of intervention
Secondary outcome method of measurement using a standard mercury sphygmomanometer
Trial phase : N/A
Target sample size : 66
Randomization : randomized
Blinding : Double blind
Placebo : used
Assignment : Parallel
Other design features :
   
Centre name 1 Bushehr University of Medical Sciences
Contact person's name Ali Movahed
Country Iran, Islamic Republic Of
Contact details : Biochemistry Lab Faculty of Medicine, Bushe hr University of Medical Sciences, Bushehr,Iran.
Bushehr
Bushehr
751472537
00987712529198

009877125200657
amirali_1957@yahoo.com
www.bpums.ac.ir
   
Ethics committee name 1 Bushehr University of Medical Sciences
Date approved 2011-09-19
Reference number B-90-12-4
Contact details : Pardis Site, Next to Salmon Farsi Hospital ,Bushehr University of Medical Sciences, Bushehr,Iran.
Bushehr
Bushehr
Iran, Islamic Republic Of
   
Sponsor 1 Department of Research, Bushehr University of Medical Sciences
Contact person's name Dr Ostovar
Contact details : Pardis Site, Next to Salmon Farsi Hospital, Department of Research,Bushehr University of Medical Science
Bushehr
Bushehr
Iran, Islamic Republic Of
751473537
00987714550178 0987714550178
00989173716538 00989173716538
0987714552228
research@bpums.ac.ir
   
Person responsible for general inquiries
Ali Movahed
Affiliated Organization name Bushehr university of medical sciences
Position/degree Ph.D Head of dept of Biochemistry
Contact details : Bushehr university of medical sciences
Bushehr
Bushehr
Iran, Islamic Republic Of
00987712529198
00987712529198
00989173711063
amirali_1957@yahoo.comamovahed58@gmail.com
   
Person responsible for scientific inquiries
Ali Movahed
Affiliated Organization name Bushehr University of Medical Sciences
Position / degree Ph.D,Head of Depart of clinical Biochemistry
Contact details : Bushehr University of Medical Sciences.Faculty of Medicine,Biochemistry Lab
Bushehr
Bushehr
Iran, Islamic Republic Of
751473537
00987712529198 00987712529198
00989713711063
amirali_1957@yahoo.com
   
Person responsible for updating data
Ali Movahed
Affiliated Organization name Bushehr university of medical sciences
Position / degree Ph.D head of dept of Biochemistry
Contact details : Bushehr university of medical sciences,Faculty of medicine,Biochemistry Lab
Bushehr
Bushehr
Iran, Islamic Republic Of
   
Registered by : Ali  Movahed
Bushehr University of Medical Sciences
Biochemistry Lab, Faculty of Medicine, Bushehr University of Medical Sciences
Bushehr
Bushehr
Iran, Islamic Republic Of
Phone: 0987712529198
Fax: 0987712520657
a.movahed@bpums.ac.ir