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

Phase 1

• Conditions: Polycystic Ovarian Syndrome
• Interventions: Procedure: Serum uc-oc; Other: drug; Drug: Metformin 850 mg twice daily for 3 months

• Registration Number: NCT02244567
• Lead Sponsor: Beni-Suef University

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.

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-13
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-30
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Serum under-carboxylated osteocalcin	Serum uc-oc	Serum uc-oc will be measured before and after 3 months of treatment with cidophage.
Placebo	drug	Other group of patients with high serum UC-OC will be given a placebo.
Metformin	Metformin 850 mg twice daily for 3 months	Cidophage 850 mg twice daily for three months will be given to the patientwith PCOS.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Nesreen Abdel Fattah Abdullah Shehata; 🇪🇬 Cairo, Egypt