Late Metabolic Effects of Metformin Therapy in Gestational Diabetes

Gestational Diabetes Clinical Trial

— DIARA2  

Official title:

Metformin Therapy for Gestational Diabetes - Metabolic Late Effects on Child at 9 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417090
• Other study ID #: DIARA2
• Status: Completed
• Start date: May 2015
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Drug:
• Insulin
Pregnant women who used insulin to treat gestational diabetes
• Metformin
Pregnant women who used metformin to treat gestational diabetes

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Oulu University Hospital

References & Publications (3)

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. — View Citation

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. — View Citation

Tertti K, Ekblad U, Vahlberg T, Rönnemaa T. Comparison of metformin and insulin in the treatment of gestational diabetes: a retrospective, case-control study. Rev Diabet Stud. 2008 Summer;5(2):95-101. doi: 10.1900/RDS.2008.5.95. Epub 2008 Aug 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic late effects	To study possible late effects of gestational diabetes treated with metformin vs insulin	9 years