Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

Zagazig University

Status and phase

Completed

Phase 1

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Treatments

Drug: Combination of Metformin hydrochloride and MI/DCI

Drug: Metformin Hydrochloride

Drug: MI/DCI combination in 40:1 ratio

Study type

Interventional

Funder types

Other

Identifiers

NCT06170463

ZU-IRB#11195-21/6-2023

Details and patient eligibility

About

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.

Enrollment

210 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.