The Gut Microbiome in Women With Polycystic Ovary Syndrome
Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role?
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2020
CompletedNovember 4, 2020
November 1, 2020
11 months
August 10, 2018
November 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
weight loss
32 weeks
Study Arms (2)
dietary advice plus myo-inositol and folic acid
ACTIVE COMPARATOR2gram myo-inositol and folic acid twice daily orally lack of consistent evidence for myo-inositol as treatment of women with PCOS
dietary advice plus liraglutide pen injector
ACTIVE COMPARATORliraglutide starting at 0.6 mg, gradually increasing up to a dose of 3 mg daily after four weeks no evidence for weight loss in women with PCOS
Interventions
dietary advice and lifestyle interventions and myo-inositol
dietary advice and lifestyle interventions and liraglutide pen injector
Eligibility Criteria
You may qualify if:
- PCOS according to ROtterdam criteria
- BMI ≥ 27 kg/m2 and at risk of metabolic syndrome or BMI ≥ 30 kg/m2
You may not qualify if:
- pregnancy
- pancreatitis (in the past)
- oral contraceptive pill use
- inflammatory bowel disease
- auto-immune disease
- immuno-modulatory drugs
- antidiabetic drugs
- anti-inflammatory drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sharon Lie Fong
Leuven, Vlaams Brabant, 3000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Lie Fong, MD, PhD
UZ Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2018
First Posted
August 22, 2018
Study Start
February 28, 2019
Primary Completion
February 1, 2020
Study Completion
July 3, 2020
Last Updated
November 4, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share