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

NCT ID: NCT00883259

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30

Brief 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.

Detailed Description

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.

Conditions

Obesity; Polycystic Ovary Syndrome; Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Experimental

Metformin treatment

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

850 mg twice daily

Placebo

Placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Microcristallyne cellulose 1 table twice daily

Interventions

Metformin

850 mg twice daily

Intervention Type: DRUG

Placebo

Microcristallyne cellulose 1 table twice daily

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women with Polycystic Ovary Syndrome (using ASRM/ESHRE criteria)
• BMI > 30
• Previous diagnosis of gestational DM

Exclusion Criteria

• Major medical conditions
• Organic pelvic diseases
• Previous pelvic surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Stefano Palomba

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Palomba, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynecology - University Magna Graecia of Catanzaro

Francesco Orio, MD

Role: PRINCIPAL_INVESTIGATOR

Endocrinology - University " Parthenope" of Naples

Achille Tolino, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynecology, University of Naples

Tommaso Simoncini, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynecology - University of Pisa

Fulvio Zullo, MD

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Unit, Cancer Center of Excellence "Tommaso Campanella" of Catanzaro

Locations

Pugliese Hospital

Catanzaro, Catanzaro, CZ, Italy

"Pugliese" Hospital

Catanzaro, Catanzaro, Italy

University of Catanzaro, Italy

Catanzaro, , Italy

Countries

Italy

Central Contacts

Stefano Palomba, MD

Role: CONTACT

stefanopalomba@tin.it

+39-0961-883234

Facility Contacts

Ingrid Tomaino, MD

Role: primary

angela.falbo@libero.it

+39-0961-883234

Other Identifiers

12/2008

Identifier Type: -

Identifier Source: org_study_id