The Gut Microbiome in Women With Polycystic Ovary Syndrome

Phase 4

Completed

• Conditions: PCOS; Obesity; Metabolic Syndrome
• Interventions: Drug: dietary advice plus Liraglutide Pen Injector; Dietary Supplement: dietary advice plus myo-inositol and folic acid

• Registration Number: NCT03642600
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Not available

Study Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Study Start: 2019-02-28
• Primary Completion: 2020-02-01
• Study Completion: 2020-07-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• PCOS according to ROtterdam criteria
• BMI ≥ 27 kg/m2 and at risk of metabolic syndrome or BMI ≥ 30 kg/m2

Exclusion Criteria

• pregnancy
• pancreatitis (in the past)
• oral contraceptive pill use
• inflammatory bowel disease
• auto-immune disease
• immuno-modulatory drugs
• antidiabetic drugs
• anti-inflammatory drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dietary advice plus liraglutide pen injector	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 myo-inositol and folic acid	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

Primary Outcome Measures

Name	Time	Method
weight loss	32 weeks

Trial Locations

Locations (1)

Sharon Lie Fong; 🇧🇪 Leuven, Vlaams Brabant, Belgium