ew strategies to lose weight for women with polycystic ovary syndrome
- Conditions
- Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]overweight and obese women with polycystic ovary syndrome (PCOS) at risk for metabolic syndrome
- Registration Number
- EUCTR2018-000677-77-BE
- Lead Sponsor
- niversity Hospital Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 60
Women aged between 18 and 40 years, with PCOS presenting anovulation, hyperandrogenism and polycystic ovarian morphology and who are at risk for metabolic syndrome:
oBMI = 27 kg/m2 and one of the risk factors of metabolic syndrome according to the International Diabetes Federation (IDF) consensus worldwide definition of the metabolic syndrome 2006
or
oBMI = 30 kg/m2
and who have no known inflammatory bowel disease or auto-immune disease
and who have access to a -20°C freezer
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
women will be excluded from participation in case of:
-pregnancy
-use of oral contraceptive pill
-use of immunomodulatory drugs, antidiabetic drugs or anti-inflammatory drugs on a daily basis
-inflammatory bowel disease, autoimmune disease
-(medical history of) pancreatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method