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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00883259
Recruitment Status : Unknown
Verified April 2013 by Stefano Palomba, University Magna Graecia.
Recruitment status was:  Not yet recruiting
First Posted : April 17, 2009
Last Update Posted : April 8, 2013
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia

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.

Condition or disease Intervention/treatment Phase
Obesity Polycystic Ovary Syndrome Gestational Diabetes Drug: Metformin Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metformin Treatment for Preventing Gestational Diabetes in High-risk Patients
Study Start Date : September 2013
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental
Metformin treatment
Drug: Metformin
850 mg twice daily

Placebo Comparator: Placebo
Placebo tablets
Other: Placebo
Microcristallyne cellulose 1 table twice daily

Primary Outcome Measures :
  1. Incidence of gestational DM in high-risk patients [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Abortion [ Time Frame: 36 months ]
  2. Pregnancy-induced hypertension [ Time Frame: 36 months ]
  3. Pre-eclampsia [ Time Frame: 36 months ]
  4. Macrosomia [ Time Frame: 36 months ]
  5. Fetal malformations [ Time Frame: 36 months ]
  6. Premature deliveries [ Time Frame: 36 months ]
  7. Intrauterine deaths [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00883259

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Contact: Stefano Palomba, MD +39-0961-883234

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Pugliese Hospital
Catanzaro, Catanzaro, CZ, Italy, 88100
"Pugliese" Hospital Not yet recruiting
Catanzaro, Italy, 88100
Contact: Ingrid Tomaino, MD    +39-0961-883234   
University of Catanzaro, Italy
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
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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

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Responsible Party: Stefano Palomba, Associate Professor, University Magna Graecia Identifier: NCT00883259     History of Changes
Other Study ID Numbers: 12/2008
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Stefano Palomba, University Magna Graecia:
High-risk patients
Pregnancy complications
Previous gestational DM

Additional relevant MeSH terms:
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Diabetes Mellitus
Polycystic Ovary Syndrome
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Pregnancy Complications
Hypoglycemic Agents
Physiological Effects of Drugs