The Gut Microbiome in Women With Polycystic Ovary Syndrome

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.

Completed

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Key information

Conditions

PCOS Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sharon Lie Fong

Leuven, Vlaams Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

weight loss

Time frame: 32 weeks

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role?

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Aug 22, 2018
Registry last updated: Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed