Clincosm LogoSign in Get a demo

The Gut Microbiome in Women With Polycystic Ovary Syndrome

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT03642600
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
16.1
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: dietary advice plus myo-inositol and folic acid
  • Drug: dietary advice plus Liraglutide Pen Injector
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role?
Actual Study Start Date :
Feb 28, 2019
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Jul 3, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. weight loss [32 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sharon Lie Fong Leuven Vlaams Brabant Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT03642600
Other Study ID Numbers:
  • S61338
First Posted:
Aug 22, 2018
Last Update Posted:
Nov 4, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Metabolic Syndrome
Syndrome
Folic Acid
Inositol
Liraglutide

Study Results

No Results Posted as of Nov 4, 2020