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U-C OC IN PCOS: Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women

Sponsor
Beni-Suef University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02244567
Collaborator
Cairo University (Other)
100
Enrollment
1
Location
3
Arms
81
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women trying to interfere with the pathophysiology of PCOS in these women as followed up by serum UC-OC levels.

Condition or Disease Intervention/Treatment Phase
  • Drug: Metformin 850 mg twice daily for 3 months
  • Procedure: Serum uc-oc
  • Other: drug
 Phase 1

Detailed Description

Under-carboxylated osteocalcin (ucOC), the precursor substrate of bone biomarker OC is a potent regulator of energy metabolism by promoting insulin production and adiponectin synthesis and decreasing fat stores.UcOC has a potential role in the physiopathology of polycystic ovary syndrome (PCOS), a common disorder defined by the constellation of anovulation, insulinresistance, hyperinsulinemia, obesity and androgen excess.Circulating ucOC concentration is related to key endocrine PCOS characteristics in a weight-dependent manner. Within the bone-pancreas loop, high ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity.We will investigate serum uc-OC responses to insulin sensitizing therapies in lean hyperandrogenic polycystic ovary syndrome (PCOS).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Metformin

Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS.

Drug: Metformin 850 mg twice daily for 3 months
This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.
Other Names:
  • Cidophage

    		•
    Active Comparator: Serum under-carboxylated osteocalcin

    Serum uc-oc will be measured before and after 3 months of treatment with cidophage.

    Procedure: Serum uc-oc
    Serum uc-oc is a bone biomarker involved in incraesing insulin in pathophysiology of PCOS. It will be measured in serum of pcos patients before and after treatment with metformin for 3 months.
    Other Names:
  • Serum undercarboxylated-osteocalcin

    		•
    Active Comparator: Placebo

    Other group of patients with high serum UC-OC will be given a placebo.

    Other: drug
    This group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC.
    Other Names:
  • vitamin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. High Serum under-carboxylated osteocalcin [3 months]

      Hyperandrogenic lean women will be diagnosed as PCOS according to Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.Serum uc-oc will be assayed when it is found to be high, metformin therapy for three months will be given to these women. Serum uc-oc will be measured again and effect of therapy will be interpreted.

    Secondary Outcome Measures

    1. Metformin therapy [3 months]

      Cidophage 850 mg twice daily will be given for three months to pcos patients who are hyperandrogenic and lean then serum uc-oc will be measured after therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 30 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Lean women BMI 25 or less

    • Hyperandrogenic clinically and/or biochemically.

    • Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria

    Exclusion Criteria:

    • BMI more than 20

    • Other causes of hyperandrogenism

    • Other causes of metabolic disorders or diabetes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nesreen Abdel Fattah Abdullah Shehata Cairo Egypt

    Sponsors and Collaborators

    • Beni-Suef University
    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Nesreen Abdel Fattah Abdullah Shehata, Lecturer of Obstetrics and Gynecology, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT02244567
    Other Study ID Numbers:
    • Beni-Suef 4
    First Posted:
    Sep 19, 2014
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by Nesreen Abdel Fattah Abdullah Shehata, Lecturer of Obstetrics and Gynecology, Beni-Suef University
    PCOS
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome
    Metformin

    Study Results

    No Results Posted as of Feb 2, 2021