Status:
COMPLETED
Inofolic NRT and the Metabolic Syndrome
Lead Sponsor:
University of Messina
Conditions:
Metabolic Syndrome
Postmenopausal Disorder
Eligibility:
FEMALE
50-60 years
Phase:
NA
Brief Summary
A prospective, randomized, controlled, open-label study will be carried out on 80 post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP III). After a written info...
Detailed Description
Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001. At least 3 of following 5 criteria must be present: 1. waist ...
Eligibility Criteria
Inclusion
- post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001.
- At least 3 of following 5 criteria must be present:
- waist circumference \> 88 cm
- Triglycerides \> 150 mg/dl
- HDL-cholesterol \< 50 mg/dl
- Fast glycemia \> 110 mg/dl
- Systolic blood pressure \> 135 mmHg. diastolic \> 85 mmHg -
Exclusion
- post-menopausal women with less than 12 months from the last menstruation
- less than 3 criteria according with ATP III
- TSH \> 3.5
- in treatment with drugs lowering glycemia or cholesterol
- allergy to cocoa
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01400724
Start Date
June 1 2011
End Date
October 1 2012
Last Update
July 16 2013
Active Locations (1)
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1
University Hospital
Messina, Italy, 98100