The Gut Microbiome in Women With Polycystic Ovary Syndrome

November 3, 2020 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Sharon Lie Fong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Dietary supplement: dietary advice plus myo-inositol and folic acid
dietary advice and lifestyle interventions and myo-inositol
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
Drug: dietary advice plus Liraglutide Pen Injector
dietary advice and lifestyle interventions and liraglutide pen injector

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight loss
Time Frame: 32 weeks
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Sharon Lie Fong, MD, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

July 3, 2020

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S61338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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