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NCT03642600 Clinical Trial

The Gut Microbiome in Women With Polycystic Ovary Syndrome

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03642600
Other study ID # S61338
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 28, 2019
Est. completion date July 3, 2020

Study information
Verified date November 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date July 3, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• dietary advice plus myo-inositol and folic acid
dietary advice and lifestyle interventions and myo-inositol
Drug:
• dietary advice plus Liraglutide Pen Injector
dietary advice and lifestyle interventions and liraglutide pen injector

Locations
Country Name City State
Belgium Sharon Lie Fong Leuven Vlaams Brabant

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary weight loss 32 weeks
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