NCT02244567

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Female
• Age: 20 Years – 30 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Polycystic Ovarian Syndrome

Interventions

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

Timeline

• Start date: 2014-09-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2014-09-19
• Last updated: 2021-02-02

Locations

1 site across 1 country: Egypt