Status:
COMPLETED
PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives
Lead Sponsor:
Federico II University
Conditions:
Polycystic Ovarian Syndrome
Insulin Sensitivity
Eligibility:
FEMALE
21-28 years
Phase:
PHASE3
Brief Summary
Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS) physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein related to insulin sensitivit...
Detailed Description
Subjects: Twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were consecutively admitted to the Endocrinology Unit of the Department of Molecular and Clinical Endocrinology and Oncology of ...
Eligibility Criteria
Inclusion
- female
- premenopausal
- obesity
- PCOS.
Exclusion
- pregnancy
- type 2 diabetes or impaired glucose tolerance
- hypothyroidism
- hyperprolactinaemia
- Cushing's syndrome
- nonclassical congenital adrenal hyperplasia
- previous (within the last 6 months) use of oral contraceptives
- glucocorticoids
- antiandrogens
- ovulation induction agents
- antidiabetic and antiobesity drugs, or other hormonal drugs.
- None of the subjects was affected by any neoplastic, metabolic, hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, and malabsorptive disorders),acute and chronic inflammations based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00948402
Start Date
December 1 2006
End Date
January 1 2009
Last Update
October 14 2009
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