The Gut Microbiome in Women With Polycystic Ovary Syndrome

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT03642600
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • dietary advice plus myo-inositol and folic acid — DIETARY_SUPPLEMENT
    dietary advice and lifestyle interventions and myo-inositol
  • dietary advice plus Liraglutide Pen Injector — DRUG
    dietary advice and lifestyle interventions and liraglutide pen injector

Study Details

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.

Key Dates

Start date
Feb 28, 2019
Status verified
Nov 2020
Primary completion
Feb 1, 2020
Completion
Jul 3, 2020

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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
  • Active Comparator: 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

Primary Outcome Measure

weight loss [ Time Frame: 32 weeks ]

Related Studies