Metformin Treatment for Preventing Gestational Diabetes in High-risk Patients
Obese pregnant PCOS patients with previous diagnosis of gestational DM will be enrolled and
allocated into two treatment arms (experimental and placebo groups). Subjects in the
experimental group will receive metformin at dosage of 850 mg twice daily, whereas subjects
in the control group will receive placebo tablets (microcristallyne cellulose) twice daily.
At baseline, all subjects will undergo clinical evaluation, serial ultrasound examinations,
and venous blood drawing to evaluate complete hormonal assays and serum fasting glucose and
insulin levels. The homeostasis model of assessment-insulin resistance, the fasting
glucose-to-insulin ratio, and the free androgen index will be also calculated. Monthly
follow-up visits will be performed for assessing maternal and fetal wellbeing.
The primary endpoint of the study will be the incidence of gestational DM. The power
analysis and the sample size calculation, performed using SamplePower release 2.0, showed
that we will need to enroll at least 40 patients for each group to yield a statistically
significant result with a power study of 90%. For categorical variables, the Pearson
chi-square test will be performed. Continuous data will be expressed either as mean and
standard deviation or median and inter-quartile range with min-max values, according to
their normal distribution, and analysed using the Student t test or Mann-Whitney U test,
respectively. Statistical significance will be set at P<0.05. The Statistics Package for
Social Science (SPSS 14.0.1; Chicago, IL, USA) will be used for statistical analysis.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Incidence of gestational DM in high-risk patients
Stefano Palomba, MD
Department of Obstetrics & Gynecology - University Magna Graecia of Catanzaro
Italy: The Italian Medicines Agency