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Metformin in Gestational Diabetes Mellitus

NCT00681460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2015-05-27

No results posted yet for this study

Summary

Gestational diabetes (GDM) is a condition that manifests as high blood sugar levels (hyperglycemia) during pregnancy in previously healthy women. It develops as a result of increased maternal body's resistance to insulin - a major hormone that allows for utilisation of glucose (sugar taken in with food) within cells. It was found out that GDM occurs more frequently in overweight women but also in women with a history of certain conditions such as polycystic ovary syndrome (PCOS). Usually, GDM disappears after pregnancy is completed but it is associated with some serious hazards for women and her unborn child, if untreated properly. Diet is a first-choice treatment but sometimes insulin therapy must be initiated if keeping a diet alone is not enough to maintain blood sugar within recommended values. Insulin therapy is effective but it requires several injections during each day and insulin is a strong acting hypoglycemic agent that may induce rapid falls in blood sugar, also dangerous for mother and unborn child.

In the investigators study, the investigators would like to investigate if metformin that is a commonly used hypoglycemic drug can be effectively used for GDM treatment. Metformin has been used successfully for a long time to treat type 2 diabetes mellitus and PCOS and, according to current data, it is not dangerous neither for mother nor for baby when used during gestation.

Conditions

Interventions

DRUG

human recombined insulin

multiple injections protocol (functional intensive insulin therapy), variable doses following dietary conditions and current metabolic status

DRUG

metformin

pills given orally twice up to three times a day, a total daily dosage 1000-2400 mg

Sponsors & Collaborators

  • K. Marcinkowski University of Medical Sciences

    lead OTHER

Principal Investigators

  • Jacek Brazert, MD.PhD.prof · K Marcinkowski University of Med Sciences, Poznan, Poland

  • Antoni J Duleba, MD.prof · University of California at Davis, Sacramento, CA, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00681460 on ClinicalTrials.gov