GC-SHealD (Glucocorticoids and Skin Healing in Diabetes) v1.1
Research type
Research Study
Full title
A double-blind, randomized, placebo-controlled phase II pilot trial investigating efficacy, safety and feasibility of 11β-hydroxysteroid dehydrogenase type 1 inhibition by AZD4017 to improve skin function and wound healing in patients with type 2 diabetes
IRAS ID
215411
Contact name
Ramzi Ajjan
Contact email
Sponsor organisation
University of Leeds
Eudract number
2017-001351-31
Clinicaltrials.gov Identifier
ESR-16-12321, AstraZeneca Reference Number
Duration of Study in the UK
0 years, 9 months, days
Research summary
Diabetes is the fastest growing health threat facing our nation
Over three million people are living with diabetes in England (three times greater than people living with cancer). 9 in 10 cases of diabetes are type 2 diabetes mellitus (T2DM), associated with an unhealthy lifestyle and obesity. By 2034 it is estimated that 1 in 10 people in England will have T2DM.
The number of devastating and costly complications of T2DM, such as foot ulcers that can lead to amputation, is also increasing. Every week over 135 leg, foot or toe amputations are carried out on people with diabetes, but around 8 in 10 of these could be prevented by improvements in foot ulcer healing. There are currently no approved treatments to improve ulcer healing – so our research is vital.
During stress, the body produces the glucocorticoid hormone cortisol which causes skin thinning, poor wound healing and increased infection risk. Cortisol is activated in skin by the enzyme 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1). Studies in patients with T2DM showed that blocking this enzyme improved disease measures including lowering weight, blood glucose and cholesterol levels. Animal models of diabetes have demonstrated that blocking this enzyme also improves skin function and wound healing. The proposed trial aims to test this in patients with T2DM using the selective 11β-HSD1 inhibitor AZD4017 which is approved for use in clinical trials.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0283
Date of REC Opinion
10 Aug 2017
REC opinion
Further Information Favourable Opinion