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| Sponsored by: |
University Magna Graecia |
|---|---|
| Information provided by: | University Magna Graecia |
| ClinicalTrials.gov Identifier: | NCT00883259 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Polycystic Ovary Syndrome Gestational Diabetes |
Drug: Metformin Other: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Metformin Treatment for Preventing Gestational Diabetes in High-Risk Patients |
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental
Metformin treatment
|
Drug: Metformin
850 mg twice daily
|
|
Placebo: Placebo Comparator
Placebo tablets
|
Other: Placebo
Microcristallyne cellulose 1 table twice daily
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stefano Palomba, MD | +39-0961-883234 | stefanopalomba@tin.it |
| Italy | |
| University of Catanzaro, Italy | |
| Catanzaro, Italy, 88100 | |
| "Pugliese" Hospital | |
| Catanzaro, Italy, 88100 | |
| Italy, Catanzaro, CZ | |
| Pugliese Hospital | |
| Catanzaro, Catanzaro, CZ, Italy, 88100 | |
| Pugliese Hospital | |
| Catanzaro, Catanzaro, CZ, Italy, 88100 | |
| Principal Investigator: | Stefano Palomba, MD | Department of Obstetrics & Gynecology - University Magna Graecia of Catanzaro |
| Principal Investigator: | Francesco Orio, MD | Endocrinology - University " Parthenope" of Naples |
| Principal Investigator: | Achille Tolino, MD | Department of Obstetrics & Gynecology, University of Naples |
| Principal Investigator: | Tommaso Simoncini, MD | Department of Obstetrics & Gynecology - University of Pisa |
| Principal Investigator: | Fulvio Zullo, MD | Gynecologic Unit, Cancer Center of Excellence "Tommaso Campanella" of Catanzaro |
More Information
| Responsible Party: | University Magna Graecia of Catanzaro ( Stefano Palomba ) |
| Study ID Numbers: | 12/2008 |
| Study First Received: | April 16, 2009 |
| Last Updated: | April 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00883259 History of Changes |
| Health Authority: | Italy: The Italian Medicines Agency |
|
High-risk patients Metformin PCOS Pregnancy complications Previous gestational DM |
|
Obesity Pregnancy Complications Metabolic Diseases Gonadal Disorders Metformin Diabetes Mellitus Endocrine System Diseases Diabetes, Gestational Overweight Ovarian Diseases Cysts Polycystic Ovarian Syndrome |
Genital Diseases, Female Body Weight Signs and Symptoms Hypoglycemic Agents Polycystic Ovary Syndrome Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Ovarian Cysts |
|
Pregnancy Complications Gonadal Disorders Physiological Effects of Drugs Overweight Diabetes, Gestational Ovarian Diseases Body Weight Genital Diseases, Female Signs and Symptoms Pathologic Processes Hypoglycemic Agents Syndrome Nutrition Disorders Obesity |
Metabolic Diseases Disease Metformin Diabetes Mellitus Endocrine System Diseases Cysts Pharmacologic Actions Adnexal Diseases Neoplasms Polycystic Ovary Syndrome Overnutrition Glucose Metabolism Disorders Ovarian Cysts |
