Metformin and Gestational Diabetes in High-risk Patients: a RCTs

Summary

Gestational diabetes mellitus (DM) is one of the most frequent complications in pregnant patients with polycystic ovary syndrome (PCOS) in 20-40% of cases and \~40% of patients with gestational DM are likely to have underlying polycystic ovarian morphology. A recent meta-analysis demonstrated a significantly higher risk of developing gestational DM \[odds ratio (OR) 2.94; 95% confidence interval (CI): 1.70-5.08\] in the PCOS population.

Metformin is an oral biguanide insulin sensitizer used for treating type-2 DM and recently introduced to treat PCOS.

At the moment, preliminary data seem to reassure regarding the use of metformin in PCOS patients showing benefits for maternal and fetal outcomes, without serious adverse events. Furthermore, well-designed randomized, controlled trials (RCTs) on this issue are lacking, thus it is not possible to either suggest or advice against the use of metformin during pregnancy for reducing gestational DM risk. To this regard, PCOS represents an intriguing model of "high-risk patients" to evaluate the efficacy of metformin for preventing DM development.

The present protocol firstly will evaluate the effects of metformin administration in reducing incidence of gestational DM in high-risk patients, such as pregnant PCOS patients.

Conditions

• Obesity
• Polycystic Ovary Syndrome
• Gestational Diabetes

Interventions

DRUG

Metformin

850 mg twice daily

OTHER

Placebo

Microcristallyne cellulose 1 table twice daily

Sponsors & Collaborators

• University Magna Graecia

  lead OTHER

Principal Investigators

• Stefano Palomba, MD · Department of Obstetrics & Gynecology - University Magna Graecia of Catanzaro

• Francesco Orio, MD · Endocrinology - University " Parthenope" of Naples

• Achille Tolino, MD · Department of Obstetrics & Gynecology, University of Naples

• Tommaso Simoncini, MD · Department of Obstetrics & Gynecology - University of Pisa

• Fulvio Zullo, MD · Gynecologic Unit, Cancer Center of Excellence "Tommaso Campanella" of Catanzaro

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2013-12-31

Countries

• Italy

Study Locations