The Gut Microbiome in Women With Polycystic Ovary Syndrome

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: PCOS; Obesity; Metabolic Syndrome

Treatments: Dietary Supplement: dietary advice plus myo-inositol and folic acid; Drug: dietary advice plus Liraglutide Pen Injector

Study type: Interventional

Funder types: Other

Identifiers

NCT03642600

S61338

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

dietary advice plus myo-inositol and folic acid

Active Comparator group

Description:

2gram myo-inositol and folic acid twice daily orally lack of consistent evidence for myo-inositol as treatment of women with PCOS

Treatment:

Dietary Supplement: dietary advice plus myo-inositol and folic acid

dietary advice plus liraglutide pen injector

Active Comparator group

Description:

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

Treatment:

Drug: dietary advice plus Liraglutide Pen Injector