How GLP-1 analogues prevent steroid-induced diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.