NCT00883259

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 obesity

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
4.4 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

3 months

First QC Date

April 16, 2009

Last Update Submit

April 5, 2013

Conditions

ObesityPolycystic Ovary SyndromeGestational Diabetes

Keywords

High-risk patientsMetforminPCOSPregnancy complicationsPrevious gestational DM

Outcome Measures

Primary Outcomes (1)

  • Incidence of gestational DM in high-risk patients

    36 months

Secondary Outcomes (7)

  • Abortion

    36 months

  • Pregnancy-induced hypertension

    36 months

  • Pre-eclampsia

    36 months

  • Macrosomia

    36 months

  • Fetal malformations

    36 months

  • +2 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Metformin treatment

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo tablets

Other: Placebo

Interventions

MetforminDRUG

850 mg twice daily

Experimental
PlaceboOTHER

Microcristallyne cellulose 1 table twice daily

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pugliese Hospital

Catanzaro, Catanzaro, CZ, 88100, Italy

Location

"Pugliese" Hospital

Catanzaro, Catanzaro, 88100, Italy

Location

University of Catanzaro, Italy

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

ObesityPolycystic Ovary SyndromeDiabetes, GestationalPregnancy Complications

Interventions

Metformin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Palomba, MD

CONTACT

+39-0961-883234stefanopalomba@tin.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

IT(3)