Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT01319994
Eligibility Criteria:
Inclusion Criteria:
* patients diagnosed with an inflammatory condition and not started yet on GC treatment or • patients with an inflammatory condition treated with GC \>20mg/d of prednisolone (or its cumulative equivalent) 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
Exclusion Criteria:
* prior therapy with metformin during the last 6 months
* known pre-existing diabetes
* pregnancy
* breastfeeding
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01319994
Study Brief:
Protocol Section:
NCT01319994