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

Polycystic Ovarian Syndrome Clinical Trial

— U-C OC IN PCOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02244567
• Other study ID #: Beni-Suef 4
• Status: Recruiting
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: June 2021

Study information

• Verified date: January 2021
• Source: Beni-Suef University
• Contact: Nesreen A Shehata, MD
• Phone: 00201227866337
• Email: nesoomar[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Egypt	Nesreen Abdel Fattah Abdullah Shehata	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Beni-Suef University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Serum under-carboxylated osteocalcin	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.	3 months
Secondary	Metformin therapy	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.	3 months

External Links

•   Pepene CE. Serum under-carboxylated osteocalcin levels in women with polycystic ovary syndrome: weight-dependent relationships with endocrine and metabolic traits. J Ovarian Res. 2013;6(1):4.