EUCTR2018-000677-77-BE
Active, not recruiting
Phase 1
ovel strategies in weight loss in women with polycystic ovary syndrome: does the gut microbiome play a role?
niversity Hospital Leuven0 sites60 target enrollmentMarch 29, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- overweight and obese women with polycystic ovary syndrome (PCOS) at risk for metabolic syndrome
- Sponsor
- niversity Hospital Leuven
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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