Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06318442

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionSteroid-Induced Diabetes, Steroid Induced Hyperglycemia

Full registry 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.

Treatments and study arms

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

Primary outcomes

Difference in Glucose toleranceThrough study completion, on day 7 dexamethasone and study medication

Glucose tolerance as measured by glucose area under the curve (AUC), in response to standardised mixed meal test (MMT) lasting for 240 minutes. This will be measured in all participants at baseline and at the end of the study medication period (after 7 days of dexamethasone and study medication).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Imperial College Healthcare NHS Trust🇬🇧 London, United Kingdom

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