New strategies to lose weight for women with polycystic ovary syndrome

Novel strategies in weight loss in women with polycystic ovary syndrome: does the gut microbiome play a role?

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000677-77-BE

Enrollment

Registered

2018-03-29

Start date

2018-06-26

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overweight and obese women with polycystic ovary syndrome (PCOS) at risk for metabolic syndrome

Interventions

Trade Name: Metformine®, Mylan Pharmaceutical Form: Tablet Trade Name: Saxenda® Pharmaceutical Form: Solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women aged between 18 and 40 years, with PCOS presenting anovulation, hyperandrogenism and polycystic ovarian morphology and who are at risk for metabolic syndrome: o BMI = 27 kg/m2 and one of the risk factors of metabolic syndrome according to the International Diabetes Federation (IDF) consensus worldwide definition of the metabolic syndrome 2006 or o BMI = 30 kg/m2 and who have no known inflammatory bowel disease or auto-immune disease and who have access to a -20°C freezer Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: women will be excluded from participation in case of: - pregnancy - use of oral contraceptive pill - use of immunomodulatory drugs, antidiabetic drugs or anti-inflammatory drugs on a daily basis - inflammatory bowel disease, autoimmune disease - (medical history of) pancreatitis

Design outcomes

Primary

Measure	Time frame
Main Objective: To test four 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 PCOS;Secondary Objective: longitudinal changes in clinical features associated with PCOS and metabolic syndrome, longitudinal changes in gut microbiome;Primary end point(s): Weight loss;Timepoint(s) of evaluation of this end point: at 4 weeks, 8 weeks, 16 weeks and 32 weeks after the first study visit	—

Measure

Time frame

Main Objective: To test four 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 PCOS;Secondary Objective: longitudinal changes in clinical features associated with PCOS and metabolic syndrome, longitudinal changes in gut microbiome;Primary end point(s): Weight loss;Timepoint(s) of evaluation of this end point: at 4 weeks, 8 weeks, 16 weeks and 32 weeks after the first study visit

—

Secondary

Measure	Time frame
Secondary end point(s): Clinical features of PCOS (cycle regularity, clinical and/or biochemical hyperandrogenism, follicle count), metabolic features (blood pressure, waist circumference, fasting glucose, fasting insulin, lipid profile), markers of low grade inflammation (C-reactive protein, lipopolysaccharides and calprotectin) and gut microbiome alterations.;Timepoint(s) of evaluation of this end point: at 4 weeks, 8 weeks, 16 weeks and 32 weeks after the first study visit	—

Measure

Time frame

Secondary end point(s): Clinical features of PCOS (cycle regularity, clinical and/or biochemical hyperandrogenism, follicle count), metabolic features (blood pressure, waist circumference, fasting glucose, fasting insulin, lipid profile), markers of low grade inflammation (C-reactive protein, lipopolysaccharides and calprotectin) and gut microbiome alterations.;Timepoint(s) of evaluation of this end point: at 4 weeks, 8 weeks, 16 weeks and 32 weeks after the first study visit

—

Countries

Belgium

Contacts

Public Contactclinical trial coordinator LUFC

university hospital leuven

myriam.welkenhuysen@uzleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026