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The Gut Microbiome in Women With Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT03642600
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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
PCOS Obesity Metabolic Syndrome Dietary Supplement: dietary advice plus myo-inositol and folic acid Drug: dietary advice plus Liraglutide Pen Injector Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : February 28, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. weight loss [ Time Frame: 32 weeks ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642600


Contacts
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Contact: Sharon Lie Fong, MD, PhD +32 16 344975 sharon.liefong@uzleuven.be
Contact: Myriam Welkenhuysen, Msc +32 16 343544 myriam.welkenhuysen@uzleuven.be

Locations
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Belgium
Sharon Lie Fong Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: sharon Lie Fong, MD    +3216344975    sharon.liefong@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Sharon Lie Fong, MD, PhD UZ Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03642600     History of Changes
Other Study ID Numbers: S61338
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Inositol
Syndrome
Metabolic Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Liraglutide
Folic Acid
Vitamin B Complex
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hematinics
Vitamins
Micronutrients
Nutrients