dr. A. Kooy
The 'Hyperinsulinaemia: Outcomes of its Metabolic Effects' (HOME) study is a 4.3-year, randomized controlled trial in 390 patients with advanced type 2 diabetes (1997-2020, and further). Effects of metformin versus placebo on clinically relevant, vascular and metabolic outcomes have been studied, and are still being studied in patients treated with insulin (without any other anti-diabetic agent). The design of the study justifies to specify clear 'metformin effects'. Several outcomes of the HOME study strengthen the worldwide positioning of metformin as the cornerstone in the treament of type 2 diabetes (like prevention of weight gain, improvement of glycaemic control with less insulin, and reduction of cardiovascular disease), or show the significance of preventable side effects of metformin (like B12 deficiency due to B12 malabsorption potentially inducing neuropathy mimicking diabetic neuropathy, becoming irreversible without B12 suppletion). The 4th PhD-project in this study, the 4th thesis, will be completed soon, to be expected in 2020.
The 'Pregnancy Outcomes: Effects of Metformin' (POEM) study is a 23-year, randomized controlled trial in 500 women with gestational diabetes mellitus (GDM, 2019-2042). Effects of metformin versus standard of care (with insulin rescues in both study arms) are studied on clinically relevant outcomes during pregnancy, at delivery and during an extra period of follow-up of 20 years. Metformin is given in the intervention group from the start of GDM (diagnosed in week 16-32 of pregnancy) until one year after delivery. This intervention period will be followed by an observation period of 19 years. This project is funded by ZonMw and by several co-sponsors. The POEM study will be performed in the 3 northern provinces Friesland, Groningen and Drenthe, and is supported by the national associations of gynaecologists (NVOG) and internists (NIV).
|Last modified:||23 November 2019 8.51 p.m.|