Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess

Phase 1

• Conditions: Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndrome

• Registration Number: EUCTR2008-005708-18-GB
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-14
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

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 ·ability to understand verbal and written instructions and informed consent

Inclusion Criteria for patients to be included in the Treatment” arm
·Patients treated with GC >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

·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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified