Actively Recruiting
The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes
Led by Imperial College London · Updated on 2024-10-02
60
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Any gender
- Pre-diabetes with HbA1c between 42 and less than 47 mmol/mol, or lifestyle-controlled diabetes with HbA1c between 48 and 52 mmol/mol, confirmed on two occasions at least 90 days apart
- Body mass index of 22.5 kg/m2 or higher
You will not qualify if you...
- Use of any diabetes medication in the past 90 days
- Current or planned pregnancy, or currently breastfeeding
- Use of glucocorticoids (topical, oral, injected) in the past 30 days or within 90 days for extended-release injected glucocorticoids
- Ongoing need for glucocorticoid treatment
- Use of medications that affect dexamethasone pharmacokinetics (e.g., phenytoin, carbamazepine, ritonavir)
- History of pancreatitis, severe kidney disease (eGFR less than 30), severe liver impairment, gallbladder or gastrointestinal diseases, heart failure, medullary thyroid cancer, or skin reactions
- History of bleeding disorders or use of anticoagulant therapies (excludes biopsy substudy only)
- Blood donation or participation in another unrelated study within the past three months
- Any other medical or psychological condition, or medication use, that could interfere with the study or affect participant safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
Research Team
K
Katharine Lazarus, MBChB, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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