Status:
COMPLETED
Glucocorticoids and Skin Healing in Diabetes (GC-SHealD)
Lead Sponsor:
University of Leeds
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study aims to investigate effects of inhibiting glucocorticoid activation on skin function and wound healing in patients with type 2 diabetes. Half of patients will be given a drug to inhibit gluc...
Detailed Description
Glucocorticoids are known to impair skin function and wound healing which are also compromised in patients with type 2 diabetes. The enzyme 11 beta-hydroxysteroid dehydrogenase type 1 (11β-HSD1) activ...
Eligibility Criteria
Inclusion
- Able and willing to consent
- Type 2 diabetes with HbA1c ≤11% (≤97 mmol/mol) at screening while taking standard therapy at a stable dose for ≥10 weeks
Exclusion
- Women of child-bearing potential
- Active leg/foot ulceration
- Clinically relevant acute electrocardiogram anomalies
- Uncontrolled hypertension
- Endocrine disorder (other than type 2 diabetes ), including type 1 or secondary diabetes (except treated hypothyroidism)
- Gilbert's disease
- Alanine aminotransferase and/or aspartate aminotransferase and/or alkaline phosphatase \>1.5x upper limit of normal (ULN)
- Bilirubin \>1.5x ULN
- Estimated glomerular filtration rate \<45 ml/min/m2
- Creatine kinase \>2x ULN
- Drug abuse within the last year
- Any glucocorticoid treatment within 3 months of screening
- Anti-coagulant medication
- Probenecid therapy
- Medical/surgical procedure or trauma during drug administration or one week after drug cessation (excluding skin biopsies)
- Involvement in trial planning and/or conduct
- Participation in other clinical study within 1 month
- Deemed inappropriate to participate by the trial team
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03313297
Start Date
April 10 2018
End Date
March 13 2019
Last Update
March 22 2019
Active Locations (1)
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1
Leeds Teaching Hospitals Trust
Leeds, United Kingdom, LS9 7TF