Effect of Pioglitazone vs Metformin on Clinical, Biochemical and Hormonal Parameters of Insulin Resistant PCOS (PCOS HOMA IR)

Mst.Sumyara Khatun

Status: Completed

Conditions: PCOS(Insulin Resistant)

Treatments: Drug: Pioglitazone 30 Mg Oral Tablet; Drug: metformin 500 mg thrice daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07472179

5161

Details and patient eligibility

About

Women with PCOS with HOMA-IR >2 fulfilling inclusion and exclusion criteria are randomly allocated into two groups: group A: pioglitazone 30 mg once daily and group B: Metformin 500 thrice daily for 3 months.Each group contains 30 participants. Outcome variables are measured after 3 months.

Full description

This study will be conducted in the Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University from the day of IRB approval. Ethical clearance will be obtained from the Institutional Review Board. Selection of the patients will be done according to inclusion and exclusion criteria. Insulin resistant PCOS patients will be included only. The patients will be explained in details regarding the objectives, rationality and potential benefits of the study. The patients will be counseled regarding the drugs and unexpected side-effect and an informed written consent will be taken. Data will be collected through interview, physical examinations and laboratory investigations. All the data will be enrolled in the data sheet for this study. The random sequence generation of permuted block will be done by computer-generated random numbers. Eligible women will be randomized to either pioglitazone group (Group A) or metformin group (Group B).

Allocation concealment will be done using serially numbered closed opaque envelopes.

Each envelope will have a card inside noting the intervention drug. Allocation will not be changed after opening the closed envelopes.

Group A: Participants will receive Tab. Pioglitazone 30mg once daily for 12 weeks.

Group B: Participants will receive Tab. Metformin 500mg thrice daily for 12 weeks.

At first baseline height, weight, waist circumference and hip circumference will be measured and BMI and waist hip ratio will be calculated. Then baseline Fasting blood glucose, Fasting insulin, Serum FSH, Serum LH, Serum Total Testosterone, Sex Hormone Binding Globulin (SHBG) will be done by collecting 5 ml blood from patient's anti cubital vein in 2nd day of menstruation and then HOMA-IR index and Free Androgen Index will be calculated. All participants will be instructed not to take any medications during the study except after consulting the physician. After 12 weeks of treatment, again BMI, waist circumference, hip circumference and waist hip ratio will be calculated and FBS, Fasting insulin, Serum FSH, Serum LH, Serum Total Testosterone, Sex Hormone Binding Globulin (SHBG) will be done and HOMA-IR index and Free Androgen Index will be calculated. Clinical record form will be developed after pre-testing. The structured clinical record form (appendix I) will include domains like demographic data, eligibility checklist visit pages (baseline, 3 month follow up) & adverse event log. The items will be demographic, clinical and laboratory variables. The form will be filled up by principal investigator. The cumulative data will be subjected to analysis.

--------------------------------------------------------------------------------

Enrollment: 60 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed case of PCOS patients according to Rotterdam criteria
• HOMA-IR >2 (Hydrie et al., 2012)
• Age: 18-35 years
• BMI: 18.5 -27.5 kg/m²

Exclusion criteria

• Presence of any endocrine disorder (hyperthyroidism, hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, hyperprolactinaemia, diabetes mellitus).
• Presence of any medical comorbidity (renal, hepatic and cardiovascular disease)
• Any medication in the last three months which would affect insulin resistance (metformin, oral contraceptive pill)
• Any contraindications to Pioglitazone (Patients with a known hypersensitivity to pioglitazone or any of its components, Diabetic ketoacidosis or type 1 diabetes) or Metformin (severe chronic diseases e.g. hepatic, renal and cardiac failure or acute complications of diabetes e.g. ketoacidosis and hyperosmolar state).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Experimental arm

Experimental group

Description:

pioglitazone 30 mg once daily

Treatment:

Drug: metformin 500 mg thrice daily

Drug: Pioglitazone 30 Mg Oral Tablet

Comparator arm

Active Comparator group

Description:

metformin 500mg thrice daily for 3 months

Treatment:

Drug: metformin 500 mg thrice daily

Drug: Pioglitazone 30 Mg Oral Tablet