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Effect of genistein supplementation on serum level of homocystein and PAI-1 (Plasminogen Activator Inhibitor-1) in postmenopausal women with type-2 diabetes mellitus.

Phase 2
Conditions
Type 2 diabetes mellitus.
Type 2 diabetes mellitus
Registration Number
IRCT20100408003664N23
Lead Sponsor
utritional Reseach Center of Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
60
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)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Homocysteine. Timepoint: Before the intervention and 12 weeks after starting. Method of measurement: ELISA.;PAI-1. Timepoint: Before the intervention and 12 weeks after starting. Method of measurement: ELISA.
Secondary Outcome Measures
NameTimeMethod
Physical activity. Timepoint: Beginning and end of intervention. Method of measurement: International Assessment of Physical Activity (IPAQ) questionnaire.;Diet. Timepoint: First, middle and end of study. Method of measurement: 3-day food record.
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