Building healthier futures with MiTy

With support from WCHRI, an international research project has been tracking Edmonton families since 2011, seeking the best treatment for women with diabetes in pregnancy and their children.

The study recruited 500 pregnant women with diabetes at four centres in Australia and 25 in Canada, including two in Edmonton, where the research is coordinated by WCHRI’s study management and clinical trials support services. The first phase of MiTy — or Metformin in women with type 2 diabetes in pregnancy — compared treatment with insulin alone and insulin with metformin on the women; the second gathered data on their babies; and the third on the now-school-aged children.

Diabetes-in-pregnancy rates have more than doubled since 2000, and continue to rise. The disease causes high blood sugar levels, which increase the risks of preeclampsia, a form of high blood pressure in pregnancy, as well as preterm birth, birth trauma and C-section, because the baby grows too large for a vaginal birth. Both mother and child are also more likely to develop Type 2 diabetes and heart disease later in life.

MiTy’s first phase showed metformin has some clear benefits: women gained less weight during pregnancy and had babies with lower birth weights than those in the placebo group. “But there have been some concerns about the drug crossing the placenta and its effects on offspring, both during and after the pregnancy,” says Andrea Haqq, a pediatric endocrinologist and professor of pediatrics at the University of Alberta.

Haqq oversaw the second and third phases of the Edmonton trials. The second, MiTy Kids, studied 283 of the babies born to the MiTy moms through to age two. It found that exposure to metformin in utero didn’t seem to affect their weight gain. The third, MiTy Tykes, is following 220 of the MiTy Kids from ages four to 11 to measure weight gain and social and cognitive development. Those results aren’t yet published.

MiTy is an example of what excellent health research looks like, Haqq says. “In my field, our highest-impact publications have come out of national and international collaboration. It’s really a team effort. When you work in a silo, you can’t do anything as impactful.”

WCHRI clinical research coordinator Heather Rylance was a constant presence through every phase of the MiTy project. Rylance saw the women once a month during their pregnancies and did home visits to collect blood samples and body measurements from their babies. The study was double-blind, meaning neither the participants nor Rylance and the researchers knew who received metformin and who was given the placebo, which helps to eliminate bias.

A long-time diabetes nurse, Rylance is very familiar with the risks of untreated diabetes. “Type 2 diabetes carries a lot of contraindications, like high blood pressure,” she says. “We want to help the mom as well as the baby stay healthy.”