Effect of genistein supplementation on serum level of homocystein and PAI-1 (Plasminogen Activator Inhibitor-1) in postmenopausal women with type-2 diabetes mellitus.
Determining the effect of genistein supplementation on serum level of homocystein and PAI-1 in postmenopausal women with type-2 diabetes mellitus.
Design
Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups. A random sequence is generated using the STATA14 software. During the random assignment, individuals in the groups will be classified according to age and BMI variables.
Settings and conduct
The aim of this study was to evaluate the effect of genistein supplementation on homocysteine and PAI-1 status in patients with T2DM. For each person, the general characteristics questionnaire, anthropometric evaluations, Food registration and IPAQ will be completed. To measure all biochemical parameters, 10 cc of venous blood is collected fast (at the beginning and end of the study). and their serum will be separated and kept at -70° until testing
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study; Postmenopausal women with history of at least one year menopause ; menopause must not be a complication of surgery; Type-2 diabetes for at least 6 months; using blood glucose lowering drugs (metformin) .
Exclusion criteria: Surgery leads to menopause; Early menopause; Use of androgen and estrogen and other steroids can affect the estrogen receptor; Insulin injections; Use of any nutritional supplements (omega-3) or anti-inflammatory and antioxidant supplements in the last 3 months or during the study; Liver and kidney failure, cardiovascular disease, breast cancer and thyroid disease; Smoking and alcohol; Patients taking NSAID, corticosteroids, antidiuretic thiazide and anti psychotics second generation.
Intervention groups
group 1 receiving genistein (2 capsule 54 mg), group 2 placebo group (2 capsule 54 mg placebo)
Main outcome variables
serum level of homocysteine and PAI-1
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100408003664N23
Registration date:2018-10-30, 1397/08/08
Registration timing:registered_while_recruiting
Last update:2018-10-30, 1397/08/08
Update count:0
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of genistein supplementation on serum level of homocystein and PAI-1 (Plasminogen Activator Inhibitor-1) in postmenopausal women with type-2 diabetes mellitus.
Public title
Effect of genistein supplementation on serum level of homocystein and PAI-1 (Plasminogen Activator Inhibitor-1) in postmenopausal women with type-2 diabetes mellitus.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Postmenopausal women with history of at least one year menopause
Type-2 diabetes for at least 6 months
using blood glucose lowering drugs (metformin)
Exclusion criteria:
Unwillingness to participate in the study
Surgery leads to menopause
Early menopause (before 40 years)
Use of androgen and estrogen and other steroids can affect the estrogen receptor
Insulin injections
Use of any nutritional supplements (omega-3) or anti-inflammatory and antioxidant supplements in the last 3 months or during the study
Liver and kidney failure, cardiovascular disease, breast cancer and thyroid disease
Smoking and alcohol
Patients taking NSAID, corticosteroids (prednisone, methylprednisolone, and hydrocortisone), antidiuretic thiazide (furosemide and hydrochlorothiazide) and anti psychotics second generation (olanzapine, clozapine)
Age
From 45 years old to 67 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to age and BMI variables.
Blinding (investigator's opinion)
Double blinded
Blinding description
the placebo and supplement will be packed in the same number in similar packages. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Science
Street address
Tabriz University of Medical Science, Attar Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.TBZMED.REC.1397.462
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11.-
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
homocysteine
Timepoint
Before the intervention and 12 weeks after starting
Method of measurement
ELISA
2
Description
PAI-1
Timepoint
Before the intervention and 12 weeks after starting
Method of measurement
ELISA
Secondary outcomes
1
Description
Physical activity
Timepoint
Beginning and end of intervention
Method of measurement
International Assessment of Physical Activity (IPAQ) questionnaire
2
Description
Diet
Timepoint
First, middle and end of study
Method of measurement
3-day food record
Intervention groups
1
Description
Intervention group: 54 mg/day genistein supplement in two capsule for 3 month
Category
Treatment - Drugs
2
Description
Control group: 54 mg/day placebo in two capsule for 3 month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital outpatient clinic Doctor Gholipour
Full name of responsible person
Hassan Braxas
Street address
Shohada boulevard
City
Boukan
Province
West Azarbaijan
Postal code
5951678467
Phone
+98 44 4623 5701
Email
Hit.boukan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutritional Reseach Center of Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Health and Nutrition School, Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 3430
Email
nut-rc@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutritional Reseach Center of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
hassan Braxas
Position
MS student in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 4625 1716
Email
h.nippon@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
hassan braxas
Position
MS student in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, Golgasht street
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 4625 1716
Email
h.nippon@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
hassan braxas
Position
MS student in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Tabriz University of Medical Sciences, Golgasht street
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 4625 1716
Email
h.nippon@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available