Counteracting Deleterious Metabolic Glucocorticoid Effects With Metformin

• Status: Completed
• Trial end date: 2021-08-18
• Target enrollment: 0
• Participant gender: Male

Summary

Supraphysiological doses of glucocorticoids (GCs) are widely prescribed as immunosuppressants and metabolic side effects such as obesity and diabetes are extremely common. Efforts to investigate and prevent these side effects are lacking. The antidiabetic drug metformin was shown in previous studies to prevent deterioration of glucose homeostasis during GC therapy in patients. However, mechanisms of metformin counteracting GC-induced side effects remain poorly understood.

In a randomized, placebo-controlled, cross-over study, 18 healthy volunteers will receive a 7-day course of prednisone with metformin or placebo. Established methods will be used to assess systemic changes in energy homeostasis and novel techniques such as metabolomics will identify underlying pathways. This will advance the understanding of energy homeostasis during GC excess, may prevent thousands of patients from GC-induced side effects and also offers a model for targeting disrupted endogenous GCs secretion.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eleonora Seelig
• Treatments: Metformin; Prednisone

Criteria

Inclusion Criteria:

• BMI 18.5 - 25 kg/m2

Exclusion Criteria:

• Any current significant disease,

• Any medication

• Glucocorticoids and/ or metformin for up to four weeks before study inclusion

• Regular alcohol intake (>30g/d),

• Regular physical activity (>4hrs per week),

• Known allergy to metformin,

• Inability or unwillingness to provide informed consent.