The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide Oral Product, Metformin Oral Tablet, Placebo.
- Who it may be relevant to
- Registry conditions: Steroid-Induced Diabetes, Steroid Induced Hyperglycemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
How GLP-1 Analogues Prevent Steroid-Induced Diabetes
Overview
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.
Interventions
- 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
Primary outcome measures
- Difference in Glucose tolerance [Time frame: Through study completion, on day 7 dexamethasone and study medication]
Secondary outcome measures (4)
- Difference in insulin secretion [Time frame: Day 6 of dexamethasone and study medication]
- Difference in insulin sensitivity [Time frame: Day 6]
- Difference in insulin sensitivity [Time frame: Day 6]
- Difference in insulin sensitivity [Time frame: Day 6]
Eligibility criteria
Inclusion criteria
- Adults ≥ 18 years;
- Male or female;
- Pre-diabetes (HbA1c ≥42 and <47 mmol/mol, or lifestyle-controlled diabetes (HbA1c ≥48 and ≤52 mmol/mol); measurements within range on two separate occasions ≥90 days apart)
- Body mass index ≥22.5 kg/m2
Exclusion criteria
- Prior treatment with any diabetes medication within 90 days;
- Current or planned pregnancy, or current breastfeeding;
- Previous treatment with GC (topical, oral, injected) within 30 days or 90 days for extended-release injected GCs (e.g. Depo-Medrone);
- Continuing requirement for GC treatment (e.g. for steroid replacement, chronic inflammatory or immunological condition);
- Treatment with medications altering DEX pharmacokinetics (e.g. phenytoin, carbamazepine, ritonavir).
- History of pancreatitis, renal disease (eGFR <30), severe hepatic impairment, gallbladder disorders, or GI disease (e.g. IBD), heart failure, history of medullary thyroid cancer (MTC), or previous skin reactions.
- History of bleeding disorders of anticoagulant therapies (exclusion from the biopsy substudy only)
- History of giving blood or having taken part in another non-related study in the last three months
- History of any other medical, psychological condition, or use of any medications, which, in the opinion of the investigators, would either interfere with the study or compromise the safety of the participant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United Kingdom · 1 center
- Imperial College Healthcare NHS Trust — London
Identifiers
NCT: NCT06318442 · 22HH8018