Clinical study
Counteracting deleterious metabolic glucocorticoid effects with metformin – The Gluco-Met Study
Background
Glucocorticoids are widely prescribed due to their immunosuppressive effect. However, metabolic side effects such as weight gain and diabetes mellitus are common. Efforts to investigate and prevent these side effects are lacking. The antidiabetic drug metformin has the potential to help patients avoid these side effects. However, the underlying mechanisms of how metformin counteracts glucocorticoid-induced side effects remain poorly understood.
Objective
To investigate how and to what extent metformin prevents the side effects of glucocorticoid treatment.
Methods
In a randomized controlled crossover trial, 18 healthy participants receive glucocorticoids in combination with metformin or a placebo for the duration of seven days. Extensive metabolic phenotyping, including heart rate variability analysis, will be conducted to assess changes in energy homeostasis.
Results
The Gluco-Met Study will advance our understanding of energy homeostasis during glucocorticoid excess and may help to reduce glucocorticoid-induced side effects in patients in need of glucocorticoid therapy.
Coordinating Center: University of Basel
Source: ClinicaTrials.gov