How GLP-1 analogues prevent steroid-induced diabetes
This study is testing if a new type of diabetes medication can help prevent high blood sugar caused by steroid treatment in people at risk for diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06318442 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of GLP-1 analogues in preventing hyperglycemia caused by a 7-day course of dexamethasone, compared to metformin. It is a double-blind, mechanistic experimental medicine study that measures glucose tolerance and insulin resistance through standardized tests. Participants will undergo assessments at baseline and after the treatment period to understand the mechanisms by which GLP-1 analogues may reduce steroid-induced hyperglycemia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pre-diabetes or lifestyle-controlled diabetes and a body mass index of 22.5 kg/m2 or higher.
Not a fit: Patients currently requiring glucocorticoid treatment or those with a history of certain medical conditions, such as pancreatitis or severe renal impairment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for preventing steroid-induced diabetes in at-risk patients.
How similar studies have performed: While there is ongoing research into GLP-1 analogues, this specific approach to preventing steroid-induced diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Karim Meeran — Imperial College London
- Study coordinator: Katharine Lazarus, MBChB, BSc
- Email: k.lazarus@imperial.ac.uk
- Phone: 07555717544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.