Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

NCT ID: NCT01594697

Last Updated: 2012-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome (PCOS) women became pregnant during metformin treatment and continued taking the drug during gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were performed at each trimester of gestation.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age 18-40 yr,
* metformin treatment for at least 3 months before entering the pregnancy,
* gestational age between 5 and 12 wk

Exclusion Criteria

* diabetes mellitus
* significant liver or renal impairment
* neoplasms and other endocrine diseases
* the use of drugs other than metformin able to interfere with glucose and insulin metabolism.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Maurizio Guido

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of Sacred Heart

Rome, Rome, Italy

Site Status

Countries

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Italy

References

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Romualdi D, De Cicco S, Gagliano D, Busacca M, Campagna G, Lanzone A, Guido M. How metformin acts in PCOS pregnant women: insights into insulin secretion and peripheral action at each trimester of gestation. Diabetes Care. 2013 Jun;36(6):1477-82. doi: 10.2337/dc12-2071. Epub 2013 Jan 11.

Reference Type DERIVED
PMID: 23315599 (View on PubMed)

Other Identifiers

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000082011

Identifier Type: -

Identifier Source: org_study_id

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