Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318442
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-06
Brief Title:
The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
How GLP-1 Analogues Prevent Steroid-Induced Diabetes
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
TITLE How GLP-1 Analogues prevent steroid-induced diabetes The GAPSID Study
DESIGN A double-blind study evaluating how GLP-1 analogues compared with metformin prevent hyperglycaemia in response to a 7-day course of dexamethasone DEX 6 mg once daily This is a mechanistic experimental medicine study
AIMS To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin
OUTCOME MEASURES
Primary Glucose tolerance in response to standardised mixed meal test MMT lasting for 240 minutes measured in all participants at baseline and on day 7 DEX
Secondary Indices of insulin resistance M-value beta-cell function acute insulin response to glucose and disposition as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp performed at baseline and on day 7 DEX
Exploratory Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies taken from a subset of approximately 8 individuals in each group
ELIGIBILITY People living with pre-diabetes or lifestyle controlled diabetes
STUDY DURATION This study will take place over 3 weeks for each partcipant Study procedures include 10 days of baseline continuous glucose monitoring CGM followed by 7 days of dexamethasone with GLP-1 metformin or placebo Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug The study will run over a period of 3 years
ANTICIPATED IMPACT Mechanistic evidence for the use of GLP-1 analogues compared with metformin in the treatment of steroid-induced diabetes
DESIGN A double-blind study evaluating how GLP-1 analogues compared with metformin prevent hyperglycaemia in response to a 7-day course of dexamethasone DEX 6 mg once daily This is a mechanistic experimental medicine study
AIMS To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin
OUTCOME MEASURES
Primary Glucose tolerance in response to standardised mixed meal test MMT lasting for 240 minutes measured in all participants at baseline and on day 7 DEX
Secondary Indices of insulin resistance M-value beta-cell function acute insulin response to glucose and disposition as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp performed at baseline and on day 7 DEX
Exploratory Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies taken from a subset of approximately 8 individuals in each group
ELIGIBILITY People living with pre-diabetes or lifestyle controlled diabetes
STUDY DURATION This study will take place over 3 weeks for each partcipant Study procedures include 10 days of baseline continuous glucose monitoring CGM followed by 7 days of dexamethasone with GLP-1 metformin or placebo Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug The study will run over a period of 3 years
ANTICIPATED IMPACT Mechanistic evidence for the use of GLP-1 analogues compared with metformin in the treatment of steroid-induced diabetes
Detailed Description:
None
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