Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndrome
Conditions
Interventions
Trade Name: Glucophage (metformin)
Product Name: Metformin
Pharmaceutical Form: Tablet
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for patients to be included in the “Prevention” arm · Patients diagnosed with a rheumatological disease and not started yet on GC treatment · minimal duration of prospective therapy 12w · dose of prednisolone =10mg/d (or equivalent GC) · ambulatory patients · patients >18 years and 20mg/d for at least 4wks · minimal duration of prospective therapy 12w · dose of prednisolone =10mg/d (or equivalent GC) · ambulatory patients · patients >18 years old · ability to understand verbal and written instructions and informed consent Inclusion Criteria for patients diagnosed with Cushing’s syndrome · Patients diagnosed with Cushing’s syndrome · ambulatory patients · patients >18 years old · ability to understand verbal and written instructions and informed consent · Exclusion Criteria · Prior therapy with metformin during the last 6 months · pre-existing diabetes · pregnancy · liver impairment: ALT and/or AST =2.5 x upper normal limit · renal impairment: serum creatinine levels =135.0 µmol/L in males and =110.0 µmol/L in females · current malignancy · patients unable to give written informed consent · or patients not understanding English and no translation available Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Prior therapy with metformin during the last 6 months · pre-existing diabetes · pregnancy · liver impairment: ALT and/or AST =2.5 x UNL · renal impairment: serum creatinine levels =135.0 µmol/L in males and =110.0 µmol/L in females · current malignancy · patients unable to give written informed consent · or patients not understanding English and no translation available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This proposal aims to prevent or treat the deleterious metabolic consequences of glucocorticoids in patients with glucocorticoid excess;Secondary Objective: To identify various metabolic parameters which might improve with the suggested therapy;Primary end point(s): Change in visceral to subcutaneous fat area ratio as assessed by CT. | — |
Countries
United Kingdom
Outcome results
None listed