Late Metabolic Effects of Metformin Therapy in Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

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.
    

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.
    

Intervention name(s): Insulin; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Pregnant women who used insulin to treat gestational diabetes; Pregnant women who used metformin to treat gestational diabetes
Other intervention name(s): Humalog, Protaphane, Novorapid; Diformin retard
Intervention MeSH terms: Metformin
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        9-year old children exposed to insulin or metformin in utero because their mothers had
        gestational diabetes
      
Biospecimen description: 
      Whole blood for DNA extraction