Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

December 13, 2023 updated by: Walid Mohamed Elnagar, Zagazig University

Combined Insulin Sensitizers as Double-Weapon to Detonate PCOS-induced Vicious Circle

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Ash Sharqia Governorate
      • Zagazig, Ash Sharqia Governorate, Egypt, 44519
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Met Group
Drug: Metformin Hydrochloride
Met Group Received metformin hydrochloride 500 mg tab 3 times Daily
Active Comparator: MI Group
Drug: MI/DCI combination in 40:1 ratio
MI-group received MI/DCI combination in 40:1 ratio twice daily
Active Comparator: MM Group
Drug: Combination of Metformin hydrochloride and MI/DCI
MM Group Received both Met and MI Groups Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of mensural pattern
Time Frame: 6 months
The Evaluation of the success rate of the applied regimens to gain mensural regular pattern in PCOS Women
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB#11195-21/6-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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