CompletedPhase 1

Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

Egypt210 participantsStarted 2022-08-01

Plain-language summary

PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age; * Residence; * level of education \& type of work; * Marital and fertility statuses, and if infertility was the main complaint; * Presence of risk factors as sedentary lifestyle; * Emotional stress and family history of PCOS; * Obesity-related medical disorders especially DM or MAFLD; * History of previous treatment for PCOS and its outcomes; * Menstrual pattern such as infrequent menstrual periods. Exclusion Criteria: * Women had other manifestations of metabolic syndrome: * Cardiac manifestations of PCOS; * Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS; * Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications; * Had morbid obesity with body mass index (BMI) \>35 kg/m2; * Causes other than PCOS for infertility, manifest DM, hepatic or pancreatic diseases.

What they're measuring

Improvement of mensural pattern

Timeframe: 6 months

Trial details

NCT IDNCT06170463

SponsorZagazig University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-03-01