Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women

Conditions
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Polycystic Ovarian Syndrome

Intervention / Treatment
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* Drug: Metformin 850 mg twice daily for 3 months
* Procedure: Serum uc-oc
* Other: drug


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS. | Drug: Metformin 850 mg twice daily for 3 months<br>* This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.<br>* Other names: Cidophage;|
| Active Comparator: Serum under-carboxylated osteocalcin<br>Serum uc-oc will be measured before and after 3 months of treatment with cidophage. | Procedure: Serum uc-oc<br>* 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.<br>* Other names: Serum undercarboxylated-osteocalcin;|
| Active Comparator: Placebo<br>Other group of patients with high serum UC-OC will be given a placebo. | Other: drug<br>* This group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC.<br>* Other names: vitamin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Serum under-carboxylated osteocalcin | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metformin therapy | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS