The Gut Microbiome in Women With Polycystic Ovary Syndrome
NCT ID: NCT03642600
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
21 participants
INTERVENTIONAL
2019-02-28
2020-07-03
Brief Summary
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* 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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dietary advice plus myo-inositol and folic acid
2gram myo-inositol and folic acid twice daily orally lack of consistent evidence for myo-inositol as treatment of women with PCOS
dietary advice plus myo-inositol and folic acid
dietary advice and lifestyle interventions and myo-inositol
dietary advice plus liraglutide pen injector
liraglutide 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
dietary advice plus Liraglutide Pen Injector
dietary advice and lifestyle interventions and liraglutide pen injector
Interventions
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dietary advice plus myo-inositol and folic acid
dietary advice and lifestyle interventions and myo-inositol
dietary advice plus Liraglutide Pen Injector
dietary advice and lifestyle interventions and liraglutide pen injector
Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 27 kg/m2 and at risk of metabolic syndrome or BMI ≥ 30 kg/m2
Exclusion Criteria
* pancreatitis (in the past)
* oral contraceptive pill use
* inflammatory bowel disease
* auto-immune disease
* immuno-modulatory drugs
* antidiabetic drugs
* anti-inflammatory drugs
18 Years
40 Years
FEMALE
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Sharon Lie Fong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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Sharon Lie Fong
Leuven, Vlaams Brabant, Belgium
Countries
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Other Identifiers
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S61338
Identifier Type: -
Identifier Source: org_study_id