NCT06318442

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

Recruiting now NA Last updated 2 October 2024

What this trial tests

NA trial testing Semaglutide Oral Product in Steroid-Induced Diabetes in 60 participants. Currently enrolling.

Timeline

15 May 2024

Primary endpoint
1 June 2027

1 June 2027

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	60
Start date	15 May 2024
Primary completion	1 June 2027
Estimated completion	1 June 2027
Sites	1 location across United Kingdom

Drugs / interventions tested

• Semaglutide Oral Product — full drug profile →
• Metformin Oral Tablet
• Placebo

Conditions studied

• Steroid-Induced Diabetes — all drugs for Steroid-Induced Diabetes →
• Steroid Induced Hyperglycemia — all drugs for Steroid Induced Hyperglycemia →

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Steroid-Induced Diabetes or Steroid Induced Hyperglycemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Semaglutide as a GLP-1 Agonist: A Breakthrough in Obesity Treatment.
   Salvador R, Moutinho CG, Sousa C, Vinha AF, et al · · 2025 · cited 9× · PMID 40143174 · DOI 10.3390/ph18030399