Spots Global Cancer Trial Database for The Gut Microbiome in Women With Polycystic Ovary Syndrome
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Trial Identification
Brief Title: The Gut Microbiome in Women With Polycystic Ovary Syndrome
Official Title: Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role?
Study ID: NCT03642600
Study Description
Brief Summary: Testing two different strategies for weight loss intervention and revealing possible changes in composition of gut microbiota, in order to provide more insight in the effect of dietary changes and weight loss treatments on gut microbiome in overweight and obese women with polycystic ovary syndrome (PCOS). The two strategies are: * dietary advice plus myo-inositol and folic acid * dietary advice plus liraglutide, glucagon-like peptide-1 (GLP-1) receptor agonist Primary outcome will be weight loss. Secondary outcomes are longitudinal changes in clinical features associated with PCOS and metabolic syndrome, longitudinal changes in gut microbiome with interventions. Subjects will be treated during 16 weeks and follow-up will take 16 weeks after stop of treatment.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Sharon Lie Fong, Leuven, Vlaams Brabant, Belgium
Contact Details
Name: Sharon Lie Fong, MD, PhD
Affiliation: UZ Leuven
Role: PRINCIPAL_INVESTIGATOR
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