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

Beni-Suef University

Status and phase: Unknown; Phase 1

Conditions: Polycystic Ovarian Syndrome

Treatments: Other: drug; Procedure: Serum uc-oc; Drug: Metformin 850 mg twice daily for 3 months

Study type: Interventional

Funder types: Other

Identifiers

NCT02244567

Beni-Suef 4

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 3 patient groups

Metformin

Active Comparator group

Description:

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

Treatment:

Drug: Metformin 850 mg twice daily for 3 months

Serum under-carboxylated osteocalcin

Active Comparator group

Description:

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

Treatment:

Procedure: Serum uc-oc

Placebo

Active Comparator group

Description:

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

Treatment:

Other: drug