Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of Metformin With or Without Folate Supplementation on Homocysteine Levels and Endothelium in Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953355
• Other study ID #: 07/009
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2009
• Last updated: November 2, 2010
• Start date: January 2004
• Est. completion date: May 2007

Study information

• Verified date: August 2009
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus patients treated with metformin.

Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if folate supplementation may improve endothelial structure and function in PCOS patients.

Description:

Fifty patients affected by PCOS without additional metabolic or cardiovascular diseases grouped in two age- and body mass index-matched treatment arms.

Interventions: A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily) (experimental group, n=25) or placebo (control group, n=25) supplementation.

In each patient were evaluated: Complete hormonal and metabolic patterns, serum Hcy, folate, vitamin B12, and endothelin-1 (ET-1) concentrations, brachial artery diameter at baseline (BAD-B) and after reactive hyperemia (BAD-RH), flow-mediated dilation (FMD), and intima-media thickness (IMT) on both common carotid arteries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• PCOS

Exclusion Criteria:

• age <18 or >35 years

• BMI >35 kg/m2

• neoplastic, metabolic, hepatic, renal, and cardiovascular disorders

• Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anovulation
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Folate plus metformin
A six-month course of metformin (1700 mg daily) plus folic acid (400 microgram daily).
• Placebo plus metformin
A six-month course of metformin (1700 mg daily) plus placebo

Locations

Country	Name	City	State
Italy	"Pugliese" Hospital	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Palomba S, Falbo A, Giallauria F, Russo T, Tolino A, Zullo F, Colao A, Orio F. Effects of metformin with or without supplementation with folate on homocysteine levels and vascular endothelium of women with polycystic ovary syndrome. Diabetes Care. 2010 Fe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial structure and function		six months	No
Secondary	Clinical outcome Metabolic outcome Endocrine outcome		six months	No