NCT06318442

The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes

How GLP-1 Analogues Prevent Steroid-Induced Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Steroid-Induced Diabetes
• Steroid Induced Hyperglycemia

Interventions

Type	Name	Description
DRUG	Semaglutide Oral Product	Oral semaglutide 3mg once uptitrated to twice daily
DRUG	Metformin Oral Tablet	Metformin modified release tablets 500mg once daily uptitrated to twice daily).
DRUG	Placebo	Placebo tablets

Timeline

• Start date: 2024-05-15
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-03-19
• Last updated: 2024-10-02

Locations

1 site across 1 country: United Kingdom