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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-06-30

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.

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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).

Conditions

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Polycystic Ovarian Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Metformin

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

Group Type ACTIVE_COMPARATOR

Metformin 850 mg twice daily for 3 months

Intervention Type DRUG

This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.

Serum under-carboxylated osteocalcin

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

Group Type ACTIVE_COMPARATOR

Serum uc-oc

Intervention Type PROCEDURE

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.

Placebo

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

Group Type ACTIVE_COMPARATOR

drug

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

drug

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

Intervention Type OTHER

Other Intervention Names

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Cidophage Serum undercarboxylated-osteocalcin vitamin

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