Determination of the effect of melatonin supplement on the activity of antioxidant enzymes in the prediabetic patients. The research is a randomized clinical trial. 70 prediabetic patients will participate in the study and will be randomly divided into two groups. At the first meeting the purpose of study will be described and asked them to fill the consent form. Group 1 will receive 30,3 mg melatonin tab for 30 days and group 2 will receive 30 placebo tab(same shape, colour, size) for 30 days and asked them to take tabs before bed time . Patients will be followed in these 30 days. The height, weight and blood pressure of the patients will record before and after the intervention and fasting blood will be collected and stored at -80 (c) refrigerator. The leves of FBS, SOD,CAT,TAC will be measured before the melatonin treatment and at least 30 days after the initiation of the treatment. In addition, a 24-h recall and a physical activity questionnaire will be completed by subjects before the melatonin treatment and at least 30 days after the initiation of the treatment. Including criteria fasting blood in the range of 100-125. Age between 35 and 50 - BMI ≥ 25 kg/m2 - Having normal physical activities.
Excluding criteria- Changing drug diet - Adopting special diets - Ceasing intake of the supplement for three days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012110411361N1
Registration date:2012-12-15, 1391/09/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-15, 1391/09/25
Registrant information
Name
Azam Mohebi
Name of organization / entity
Public Health Departmentof Tehran University
Country
Iran (Islamic Republic of)
Phone
+98 21 4427 4674
Email address
a-mohebi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effect of melatonin supplement on the activity of antioxidant enzymes in prediabetes patients
Public title
effect of melatonin supplement on oxidative stress
Purpose
Prevention
Inclusion/Exclusion criteria
Requirements to select patients:The patients whose affliction with prediabetes are confirmed and their blood sugar before breakfast is in the range of 100-125;age between 35 and 50;BMI ≥ 25 kg/m2;Having normal physical activities ;Interested in the research project
Factors preventing patients from being included in the study ,Smoking, and using alcohol and other drugs ;Professional athletes ,Persons used the drugs reducing blood lipid, heart drugs, hypertension drugs, diuretics, vitamin supplements or any antioxidant three months before the intervention ,Using anti-inflammatory drugs, the drugs or materials having interference with melatonin supplement, such as vafarin, within three months before the intervention ;Having a record of ischemic heart disease, stroke, kidney failure, cancer, chemotherapy, radiotherapy and other diseases in which free radicals are a cause ;Women in the period of pregnancy and breastfeeding;Women with premature menopause;People working at night shifts ;People engaged in shift working
Removing patients from the population:Changing drug diet ;Adopting special diets;Ceasing intake of the supplement for three days
Age
From 35 years old to 50 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
Tehran University of Medical Sciences
Street address
16 Azar st, Poursina st, Keshavarz blv
City
Tehran
Postal code
Approval date
2012-04-15, 1391/01/27
Ethics committee reference number
62789
Health conditions studied
1
Description of health condition studied
prediabetes
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test
Primary outcomes
1
Description
activity of SOD enzyme
Timepoint
befor intervention,1 month after intervention
Method of measurement
blood test,U/gHb,kit
2
Description
activity of CAT enzyme
Timepoint
befor intervention,1 month after intervention
Method of measurement
blood test,k/gHb,kit
3
Description
TAC serum
Timepoint
befor intervention,1 month after intervention
Method of measurement
blood test,Mmol/ml,kit
Secondary outcomes
1
Description
blood pressure
Timepoint
befor intervention,1 month after intervention
Method of measurement
Sphygmomanometer,mmHg
2
Description
fasting blood sugar
Timepoint
befor intervention,1 month after intervention
Method of measurement
blood test,Mg/dl
3
Description
height
Timepoint
before intervention
Method of measurement
stadiometer,cm
4
Description
weight
Timepoint
before intervention,30 days after intervention
Method of measurement
Scale ,kg
5
Description
BMI
Timepoint
befor intervention,30 days after intervention
Method of measurement
calculate, kg/cm2
Intervention groups
1
Description
intervention group:melatonin supplement 3mg for 1 month befor sleep
Category
Prevention
2
Description
control group: corn starch placebo before sleep
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
14 Masum Health Center
Full name of responsible person
Dr Sarvi
Street address
Rezvan alley, Sobhani st, Ghazvin st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research -Tehran University of Medical Science
Full name of responsible person
Dr Saedi Ahmad
Street address
Tehran
City
Tehran
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 -Tehran University of Medical Science
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
Department of Nutrition and Biochemistry
Full name of responsible person
Azam Mohebi
Position
Master of nutritional science
Other areas of specialty/work
Street address
Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences.
City
Tehran
Postal code
Phone
+98 21 6640 2095
Fax
Email
az-mohebi@razi.tums.ac.irazam_mohebi@yahoo.cm
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Nutrition and Biochemistry
Full name of responsible person
Dr Saedi Ahmad
Position
PhD nutrition
Other areas of specialty/work
Street address
Tehran University of Medical Sciences,School of Public Health, ,Department of Nutrition and Biochemistry
City
Tehran
Postal code
Phone
+98 21 6640 2095
Fax
Email
a_saedi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azam Mohebi
Position
Msc nutrition
Other areas of specialty/work
Street address
12, Sonbol alley, Kabiri st, Hemmat
City
Tehran
Postal code
1475655143
Phone
+98 21 4427 4674
Fax
Email
az-mohebi@razi.tums.ac.irazam_mohebi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)