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The Gut Microbiome in Women With Polycystic Ovary Syndrome

Primary Purpose

PCOS, Obesity, Metabolic Syndrome

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

dietary advice plus myo-inositol and folic acid

dietary advice plus Liraglutide Pen Injector

About this trial

This is an interventional treatment trial for PCOS

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Sharon Lie Fong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

dietary advice plus myo-inositol and folic acid

dietary advice plus liraglutide pen injector

Arm Description

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

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

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

Full Information

NCT ID

NCT03642600

First Posted

August 10, 2018

Last Updated

November 3, 2020

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT03642600

Brief Title

The Gut Microbiome in Women With Polycystic Ovary Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

February 28, 2019 (Actual)

Primary Completion Date

February 1, 2020 (Actual)

Study Completion Date

July 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PCOS, Obesity, Metabolic Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dietary advice plus myo-inositol and folic acid

Arm Type

Active Comparator

Arm Description

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

Arm Title

dietary advice plus liraglutide pen injector

Arm Type

Active Comparator

Arm 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

Intervention Type

Dietary Supplement

Intervention Name(s)

dietary advice plus myo-inositol and folic acid

Intervention Description

dietary advice and lifestyle interventions and myo-inositol

Intervention Type

Drug

Intervention Name(s)

dietary advice plus Liraglutide Pen Injector

Intervention Description

dietary advice and lifestyle interventions and liraglutide pen injector

Primary Outcome Measure Information:

Title

weight loss

Time Frame

32 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon Lie Fong, MD, PhD

Organizational Affiliation

UZ Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sharon Lie Fong

City

Leuven

State/Province

Vlaams Brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Gut Microbiome in Women With Polycystic Ovary Syndrome

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