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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02244567

Acronym

U-C OC IN PCOS

Enrollment

100

Registered

2014-09-19

Start date

2014-09-30

Completion date

2021-06-30

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovarian Syndrome

Keywords

PCOS

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).

Interventions

DRUGMetformin 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.

PROCEDURESerum 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.

OTHERdrug

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 30 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

Primary ContactNesreen A Shehata, MD

nesoomar@yahoo.com00201227866337

Backup ContactAbdelgany M Hassan, MD

abdelgany2@gmail.com00201017801604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026