NCT03117517

Brief Summary

Objective:

  1. 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. 2.To evaluate insulin resistance in all the groups at baseline and after 3 months of treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2017

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 2, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

March 21, 2017

Results QC Date

November 29, 2019

Last Update Submit

February 17, 2020

Conditions

Polycystic Ovarian Syndrome

Keywords

PCOS

Outcome Measures

Primary Outcomes (1)

  • Cytokines and Chemokines Measurements

    IL-6 and IL-8 levels by ELISA method using commercially available kits.

    Baseline and after 3 Months

Secondary Outcomes (2)

  • Hormonal Profiles

    Baseine and after 3 Months

  • Insulin Resistance

    Baseline and after 3 months

Study Arms (2)

Metformin

EXPERIMENTAL

Drug intervention: Metformin 500 mg tablet twice orally for 3 months

Drug: Metformin

Metformin, pioglitazone

ACTIVE COMPARATOR

Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months

Drug: Metformin, Pioglitazone

Interventions

MetforminDRUG

Metformin (1000 mg)

Also known as: Glucophage
Metformin
Metformin, PioglitazoneDRUG

Metformin (1000 mg) Pioglitazone (30 mg)

Also known as: Glucophage, Zolid
Metformin, pioglitazone

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPCOS women with oligo-anovulation, hirsutism, elevated serum testosterone levels, menstrual cycle irregulary.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically diagnosed patients of PCOS.
  • Must Swallow the tablet(s).
  • Must give informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardan Medical Complex

Mardan, Khyber Pukhtunkhwah, 25000, Pakistan

Location

Related Publications (5)

  • Peng 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: 26849353BACKGROUND

  • Ortega-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: 15598674BACKGROUND

  • Xu 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: 25096410RESULT

  • Velazquez 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: 8177055RESULT

  • Palomba 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: 24873996RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminPioglitazone

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsThiazolidinedionesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

No blinding No measure of visceral adiposity.

Results Point of Contact

Title
Dr. Mohsin Shah (Associate Professor)
Organization
Khyber Medical University
mohsin.ibms@kmu.edu.pk
3429620074

Study Officials

  • Mohsin Shah, PhD

    Institute oF Basic Medical Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 18, 2017

Study Start

March 20, 2017

Primary Completion

August 29, 2017

Study Completion

March 7, 2018

Last Updated

March 2, 2020

Results First Posted

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

The data collected at baseline and after treatment with metformin alone for 3 months which is ARM #1 in this study and treatment of patients with combination of metformin and pioglitazone which is ARM # 2 in this study for three months. Blood samples will be collected and processed for analysis. All the data collected from these patients at baseline and after 3 months of treatment will be available to other researchers in the form of publication and rest of the materials can be obtained from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
March 31, 2018 for next 5 years
Access Criteria
Publication

Locations

PA(1)