Clinical trial · Interventional
Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome
Effects of Metformin and Combination of Metformin and Pioglitazone on Plasma Interleukin-6 and Interleukin-8 Levels in Polycystic Ovarian Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective: 1. To investigate the changes in the levels of interleukin-6 and interleukin-8 after 3 months treatment with metformin alone and combination of metformin and pioglitazone in patients with polycystic ovarian syndrome (PCOS). 2. To evaluate insulin resistance in all the groups at baseline and after 3 months of treatment. Design: Two-Arm Randomized Clinical trial. Setting: Out-Patient Department (OPD) of Mardan Medical Complex, Khyber Medical University. Patient(s): One hundred and two patients with PCOS. Intervention(s): 51 women will receive metformin according to the body weight with maximum dose of 1000 mg (BD) daily. Remaining 51 will receive metformin and pioglitazone combination according to the body weight with maximum dose of 1000 mg and 30 mg (BD) daily. Main outcomes measure(s): Serum concentrations of fasting blood glucose, insulin, homeostatic model assessment for insulin resistance (HOMA-IR), follicle stimulating hormone (FSH), luteinizing hormone (LH), interleukin-6 (IL-6) and i-nterleukin-8 (IL-8).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
| Metformin, Pioglitazone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Drug intervention: Metformin 500 mg tablet twice orally for 3 months
- interventionNames
- Drug: Metformin
- type
- ACTIVE_COMPARATOR
- label
- Metformin, pioglitazone
- description
- Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months
- interventionNames
- Drug: Metformin, Pioglitazone
Primary outcomes (1)
- measure
- Cytokines and Chemokines Measurements
- timeFrame
- Baseline and after 3 Months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically diagnosed patients of PCOS. * Must Swallow the tablet(s). * Must give informed consent. Exclusion Criteria: * Women with cushing syndrome, hyperprolactinemia. * Late onset congenital adrenal hyperplasia, androgen-producing tumors, pregnancy. * Insulin dependent diabetes. * Thyroid disease. * Medications that alters the biochemical or hormonal profile.
References
Publications (5)
- BACKGROUNDPeng Z, Sun Y, Lv X, Zhang H, Liu C, Dai S. Interleukin-6 Levels in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. PLoS One. 2016 Feb 5;11(2):e0148531. doi: 10.1371/journal.pone.0148531. eCollection 2016. PMID 26849353
- BACKGROUNDOrtega-Gonzalez C, Luna S, Hernandez L, Crespo G, Aguayo P, Arteaga-Troncoso G, Parra A. Responses of serum androgen and insulin resistance to metformin and pioglitazone in obese, insulin-resistant women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Mar;90(3):1360-5. doi: 10.1210/jc.2004-1965. Epub 2004 Dec 14. PMID 15598674
- RESULTXu X, Du C, Zheng Q, Peng L, Sun Y. Effect of metformin on serum interleukin-6 levels in polycystic ovary syndrome: a systematic review. BMC Womens Health. 2014 Aug 5;14:93. doi: 10.1186/1472-6874-14-93. PMID 25096410
- RESULTVelazquez EM, Mendoza S, Hamer T, Sosa F, Glueck CJ. Metformin therapy in polycystic ovary syndrome reduces hyperinsulinemia, insulin resistance, hyperandrogenemia, and systolic blood pressure, while facilitating normal menses and pregnancy. Metabolism. 1994 May;43(5):647-54. doi: 10.1016/0026-0495(94)90209-7. PMID 8177055
- RESULTPalomba S, Falbo A, Chiossi G, Orio F, Tolino A, Colao A, La Sala GB, Zullo F. Low-grade chronic inflammation in pregnant women with polycystic ovary syndrome: a prospective controlled clinical study. J Clin Endocrinol Metab. 2014 Aug;99(8):2942-51. doi: 10.1210/jc.2014-1214. Epub 2014 May 29. PMID 24873996