Ignite Creation Date:
2024-05-06 @ 10:39 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03313297
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2017-10-05
Brief Title:
Glucocorticoids and Skin Healing in Diabetes GC-SHealD
Sponsor:
University of Leeds
Organization:
University of Leeds
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GC-SHealD
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 glucocorticoid activation and the other half will be given a placebo
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 activates glucocorticoids in target tissues including skin Pre-clinical data demonstrate that 11β-HSD1 inhibition improves skin function and wound healing but this has not been investigated in man
Using the 11β-HSD1 inhibitor AZD4017 we will investigate if
1 Oral AZD4017 inhibits 11β-HSD1 activity in skin
2 AZD4017 is safe and well-tolerated in patient with T2DM
3 Oral AZD4017 regulates skin function
4 Systemic glucocorticoid levels and skin 11β-HSD1 activity independently or in combination correlate with measures of skin function
Study feasibility will also be assessed if successful data from this pilot study will inform power calculations for a future trial to investigate the ability of 11β-HSD1 inhibition to promote foot ulcer healing in type 2 diabetes
Using the 11β-HSD1 inhibitor AZD4017 we will investigate if
1 Oral AZD4017 inhibits 11β-HSD1 activity in skin
2 AZD4017 is safe and well-tolerated in patient with T2DM
3 Oral AZD4017 regulates skin function
4 Systemic glucocorticoid levels and skin 11β-HSD1 activity independently or in combination correlate with measures of skin function
Study feasibility will also be assessed if successful data from this pilot study will inform power calculations for a future trial to investigate the ability of 11β-HSD1 inhibition to promote foot ulcer healing in type 2 diabetes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None