Insulin Resistance Syndrome, Polycystic Ovary Syndrome (PCOS) Women
Conditions
Keywords
Polycystic Ovary Syndrome, Metformin, Insulin Resistance
Brief summary
This prospective longitudinal interventional study aims to evaluate the effects of routine metformin therapy on metabolic, iron-related, erythropoietin, lipid, and hematological parameters in adult women with polycystic ovary syndrome (PCOS). Participants diagnosed with PCOS according to established diagnostic criteria receive routine metformin therapy for six months as part of standard clinical care. Clinical and laboratory assessments are performed at baseline, three months, and six months to evaluate changes in insulin resistance, fasting blood glucose, fasting serum insulin, serum ferritin, serum iron, erythropoietin (EPO), lipid profile, and hematological indices. The study also examines the relationships between metabolic, iron-related, and hematological biomarkers during metformin treatment.
Detailed description
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders affecting women of reproductive age and is frequently associated with insulin resistance, dyslipidemia, obesity, and an increased risk of metabolic complications. Although metformin is widely prescribed to improve insulin sensitivity in women with PCOS, its effects on iron metabolism, erythropoietin concentrations, and hematological parameters remain incompletely understood. This prospective longitudinal interventional study was conducted among adult women with PCOS attending obstetrics and gynecology clinics of the Jordanian Ministry of Health. Eligible participants received routine metformin therapy (500 mg twice daily) for six months as part of standard clinical practice. No additional behavioral, lifestyle, dietary, or educational interventions were provided as part of the study protocol. Clinical and laboratory assessments were performed at baseline, after three months, and after six months of treatment. Outcome measures included body mass index (BMI), fasting blood glucose (FBG), fasting serum insulin, homeostatic model assessment of insulin resistance (HOMA-IR), lipid profile (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol), serum ferritin, serum iron, erythropoietin (EPO), hemoglobin concentration, complete blood count, and red blood cell indices. The primary objective was to determine the effects of routine metformin therapy on insulin resistance, iron metabolism, erythropoietin concentrations, and hematological parameters in women with PCOS. Secondary objectives included evaluating changes in lipid profile and investigating the associations among metabolic, iron-related, and hematological biomarkers during the six-month follow-up period. The findings of this study are expected to improve understanding of the metabolic and hematological effects of routine metformin therapy in women with PCOS and to clarify the relationship between insulin resistance, iron homeostasis, erythropoietin, and metabolic outcomes in this population.
Interventions
DRUGMetformin
Metformin hydrochloride tablets, 500 mg administered orally twice daily for six months as part of routine clinical management of women with polycystic ovary syndrome (PCOS).
Sponsors
Jerash Private University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This was a prospective single-group longitudinal interventional study. All enrolled participants with polycystic ovary syndrome (PCOS) received routine metformin therapy (500 mg twice daily) for six months. Clinical and laboratory assessments were performed at baseline, three months, and six months to evaluate changes in metabolic, iron-related, lipid, erythropoietin, and hematological parameters. No parallel control group was included.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women aged 18-45 years. * Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam diagnostic criteria. * Eligible for routine metformin therapy as determined by the treating gynecologist. * Willing and able to provide written informed consent. * Willing to attend scheduled follow-up visits and complete all study assessments over the six-month study period.
Exclusion criteria
* Pregnancy or breastfeeding. * Diagnosis of type 1 diabetes mellitus or established type 2 diabetes requiring insulin therapy. * History of chronic kidney disease, chronic liver disease, hematological disorders, malignancy, or other severe systemic diseases. * Current use of medications known to affect glucose metabolism, iron metabolism, erythropoietin levels, or hematological parameters within the previous three months, other than routine metformin prescribed as part of the study. * Known hypersensitivity or contraindication to metformin. Inability or unwillingness to complete the scheduled follow-up assessments. * Participation in another interventional clinical trial during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin resistance (HOMA-IR) | Baseline and 6 months | To evaluate the change in insulin resistance using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) following six months of routine metformin therapy in women with polycystic ovary syndrome. |
| Change in serum ferritin concentration | Baseline and 6 months | To evaluate the change in serum ferritin concentration after six months of routine metformin therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting blood glucose | Baseline and 6 months | — |
| Change in fasting serum insulin | Baseline and 6 months | — |
| Change in serum iron concentration | Baseline and 6 months | — |
| Change in hematological parameters | Baseline and 6 months | Changes in hemoglobin concentration, red blood cell indices, and complete blood count parameters. |
| Change in body mass index (BMI) | Baseline and 6 months | — |
Countries
Jordan
Outcome results
None listed