Metformin in Gestational Diabetes Mellitus

NCT00681460 | Completed

• 1 other identifier: KMUMS 705/07
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes, Gestational; Insulin Resistance

Keywords

gestational diabetes; birth weight; fetal growth; insulin resistance; oxidative stress; inflammatory reaction; Fetal Development

Outcome Measures

Primary Outcomes (1)

• newborn weight

  first hour of life

Secondary Outcomes (1)

• parameters of metabolic control in mother and newborn, insulin resistance, inflammatory reaction, oxidative stress, fetal growth,

  during pregnancy and up to twelve hours after delivery

Study Arms (2)

1

ACTIVE COMPARATOR

gestational diabetes, insulin therapy

Drug: human recombined insulin

2

EXPERIMENTAL

gestational diabetes, metformin therapy

Drug: metformin

Interventions

human recombined insulin DRUG

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

1

metformin DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes diagnosed during pregnancy
• single pregnancy
• ineffective diet therapy

You may not qualify if:

• pregestational diabetes
• fetal malformation
• multiple pregnancy
• contraindications to metformin therapy (liver or kidney disease)

Sponsors & Collaborators

• K. Marcinkowski University of Medical Sciences: lead

Study Sites (1)

Div of Obstetrics and Women's Diseases, Dept of Obstetrics and Gynecology, K Marcinkowski Univ of Med Sciences

Poznan, 60-535, Poland

Location

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance; Birth Weight; Inflammation

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jacek Brazert, MD.PhD.prof

  K Marcinkowski University of Med Sciences, Poznan, Poland

  STUDY CHAIR

• Antoni J Duleba, MD.prof

  University of California at Davis, Sacramento, CA, USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Obstetrics and Women's Diseases, Senior Lecturer

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

PL (1)