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

Sponsor
Imperial College London
Study ID
NCT06318442
Status
Recruiting
Apply to this trial

Conditions

  • Steroid Induced Hyperglycemia
  • Steroid-Induced Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
Sep 2024
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Once daily semaglutide
    Once daily semaglutide 3 mg (uptitrated to 3 mg twice daily after two days).
  • Active Comparator: - Metformin
    Metformin modified release tablets (500mg once daily for the first two days, then 500 mg twice daily).
  • Placebo Comparator: Placebo
    Placebo tablets

Primary Outcome Measure

Difference in Glucose tolerance [ Time Frame: Through study completion, on day 7 dexamethasone and study medication ]

Central Contacts

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