Late Metabolic Effects of Metformin Therapy in Gestational Diabetes
NCT ID: NCT02417090
Last Updated: 2020-12-11
Study Results
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Basic Information
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COMPLETED
173 participants
OBSERVATIONAL
2015-05-31
2019-12-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Metformin therapy
9-year-old children whose mothers used metformin for gestational diabetes
Metformin
Pregnant women who used metformin to treat gestational diabetes
Insulin therapy
9-year-old children whose mothers used insulin for gestational diabetes
Insulin
Pregnant women who used insulin to treat gestational diabetes
Interventions
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Insulin
Pregnant women who used insulin to treat gestational diabetes
Metformin
Pregnant women who used metformin to treat gestational diabetes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
9 Years
10 Years
ALL
No
Sponsors
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Oulu University Hospital
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Harri Niinikoski
MD, Pediatric Endocrinologist, Professor of Nutrition in Medicine.
Principal Investigators
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Harri J Niinikoski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Turku
References
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Tertti K, Ekblad U, Koskinen P, Vahlberg T, Ronnemaa 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.
Ijas H, Vaarasmaki 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, Vahlberg T, Ronnemaa 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.
Huhtala M, Ronnemaa T, Tertti K, Niinikoski H, Paavilainen E. Maternal and umbilical cord serum lipids in gestational diabetes predict offspring insulin secretion and resistance at the age of nine years. Metabolomics. 2025 Jun 22;21(4):87. doi: 10.1007/s11306-025-02281-9.
Huhtala MS, Ronnemaa T, Paavilainen E, Niinikoski H, Pellonpera O, Juhila J, Tertti K. Prediction of pre-diabetes and type 2 diabetes nine years postpartum using serum metabolome in pregnant women with gestational diabetes requiring pharmacological treatment. J Diabetes Complications. 2023 Jul;37(7):108513. doi: 10.1016/j.jdiacomp.2023.108513. Epub 2023 May 26.
Huhtala M, Nikkinen H, Paavilainen E, Niinikoski H, Vaarasmaki M, Loo BM, Ronnemaa T, Tertti K. Comparison of glucose metabolism and anthropometry in women with previous gestational diabetes treated with metformin vs. insulin: 9-year follow-up of two randomized trials. Acta Obstet Gynecol Scand. 2022 May;101(5):514-523. doi: 10.1111/aogs.14343. Epub 2022 Mar 11.
Paavilainen E, Tertti K, Nikkinen H, Veijola R, Vaarasmaki M, Loo BM, Tossavainen P, Ronnemaa T, Niinikoski H. Metformin versus insulin therapy for gestational diabetes: Effects on offspring anthropometrics and metabolism at the age of 9 years: A follow-up study of two open-label, randomized controlled trials. Diabetes Obes Metab. 2022 Mar;24(3):402-410. doi: 10.1111/dom.14589. Epub 2021 Nov 24.
Other Identifiers
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DIARA2
Identifier Type: -
Identifier Source: org_study_id