DIARA2: Late Metabolic Effects of Metformin Therapy in Gestational Diabetes
Study Details
Study Description
Brief Summary
Metformin in widely used as the treatment of gestational diabetes. However, it is not known whether exposure to metformin in utero has late metabolic effects on the child.
In this study the investigators investigate metabolism (oral glucose tolerance test, insulin, plasma lipoproteins, inflammation markers as well as body composition by DEXA (dual energy X-ray absorption) and MRI) in 9 year-old children whose mothers used either metformin of insulin during pregnancy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Gestational diabetes is usually managed with diet and insulin, if needed. However, oral metformin therapy has been also used to treat gestational diabetes and the short-term studies have shown that it is effective and also safe for the child. However, long-term studies of its effects are lacking.
Previously, several years ago, 217 pregnant women with gestational diabetes in Turku and 100 such women in Oulu, Finland, were randomised to either insulin or metformin therapy to treat gestational diabetes. In those studies, the metformin therapy proved to be safe in the short-term.
Now these children are 5-9 years old. In the present study these children (as well as their mothers) are investigated when the children are 9 years old. The aim is to study whether the metformin given during the pregnancy has any metabolic effects on the child at 9 years of age. To do this these families are contacted by mail and asked to participate into the study.
At 9 years of age, the following investigations will be made (after consent from the child and family): oral glucose tolerance test+insulin+c-peptide, plasma lipoproteins, adiponectin, PAI-1 (plasminogen activator inhibitor-1), IL-6 (interleukin-6), HS CRP (high-sensitivity C-reactive protein), p-metabolomics, DEXA, abdominal MRI, WISC IV (Wechsler intelligence scale for children IV)cognitive testing, BRIEF questionnaire, questionnaire about diet and health habits. The study subjects will also be clinically examined and measured and blood pressure will be taken.
All analyses are performed at the University hospital laboratory and radiology facilities using modern techniques. The amount of blood taken is limited and also radiation dose from DEXA is very small. The data are kept behind lock and key. Statistical analyses will be performed to study whether children exposed to metformin during pregnancy have any differences in their metabolism and well-being than those exposed to insulin. This study involves no new medical treatments to the study subjects.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Metformin therapy 9-year-old children whose mothers used metformin for gestational diabetes |
Drug: Metformin
Pregnant women who used metformin to treat gestational diabetes
Other Names:
|
| Insulin therapy 9-year-old children whose mothers used insulin for gestational diabetes |
Drug: Insulin
Pregnant women who used insulin to treat gestational diabetes
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Metabolic late effects [9 years]
To study possible late effects of gestational diabetes treated with metformin vs insulin
Eligibility Criteria
Criteria
Inclusion Criteria:
- all children whose mothers used either metformin or insulin to treat gestational diabetes and were involved in the previous metformin study in Turku or Oulu, Finland
Exclusion Criteria:
- severe congenital malformations
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Turku University Hospital
- Oulu University Hospital
Investigators
- Principal Investigator: Harri J Niinikoski, MD, PhD, University of Turku
Study Documents (Full-Text)
None provided.More Information
Publications
- Ijäs H, Vääräsmäki M, Morin-Papunen L, Keravuo R, Ebeling T, Saarela T, Raudaskoski T. Metformin should be considered in the treatment of gestational diabetes: a prospective randomised study. BJOG. 2011 Jun;118(7):880-5. doi: 10.1111/j.1471-0528.2010.02763.x. Epub 2010 Nov 18.
- Tertti K, Ekblad U, Koskinen P, Vahlberg T, Rönnemaa T. Metformin vs. insulin in gestational diabetes. A randomized study characterizing metformin patients needing additional insulin. Diabetes Obes Metab. 2013 Mar;15(3):246-51. doi: 10.1111/dom.12017. Epub 2012 Oct 24.
- DIARA2