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The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes 60 Double-Blind Lifestyle

Recruiting
Clinical Trial NCT06318442 is an interventional study for Steroid-Induced Diabetes, Steroid Induced Hyperglycemia that is recruiting. It started on May 15, 2024 with plans to enroll 60 participants. Led by Imperial College London, it is expected to complete by June 1, 2027. The latest data from ClinicalTrials.gov was last updated on October 2, 2024.
Brief Summary
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 m...

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Official Title

How GLP-1 Analogues Prevent Steroid-Induced Diabetes

Conditions
Steroid-Induced DiabetesSteroid Induced Hyperglycemia
Other Study IDs
  • 22HH8018
NCT ID Number
NCT06318442
Start Date (Actual)
2024-05-15
Last Update Posted
2024-10-02
Completion Date (Estimated)
2027-06-01
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalOnce daily semaglutide
Once daily semaglutide 3 mg (uptitrated to 3 mg twice daily after two days).
Semaglutide Oral Product
Oral semaglutide 3mg once uptitrated to twice daily
Active Comparator- Metformin
Metformin modified release tablets (500mg once daily for the first two days, then 500 mg twice daily).
Metformin Oral Tablet
Metformin modified release tablets 500mg once daily uptitrated to twice daily).
Placebo ComparatorPlacebo
Placebo tablets
Placebo
Placebo tablets
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Difference in Glucose tolerance
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).
Through study completion, on day 7 dexamethasone and study medication
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Difference in insulin secretion
This will be measured by the acute insulin response to glucose based on the incremental AUC for insulin during the first 10 minutes of an IVGTT and the second phase insulin response based on incremental AUC for insulin during +10 to +60 minutes. This will be measured in a subset of patients (10 from each randomisation group), performed at baseline and on day 6 of dexamethasone and study medication
Day 6 of dexamethasone and study medication
Difference in insulin sensitivity
This will be measured by the M value, based on the glucose infusion rate during the last 60 minutes of a hyperinsulinaemic-euglycaemic clamp. This will be measured in a subset of patients (10 from each randomisation group), performed at baseline and on day 6 of dexamethasone and study medication
Day 6
Difference in insulin sensitivity
This will be measured by the M/I index, calculated by the M value divided by the mean steady state insulin levels during the last 60 minutes of a hyperinsulinaemic-euglycaemic clamp. This will be measured in a subset of patients (10 from each randomisation group), performed at baseline and on day 6 of dexamethasone and study medication
Day 6
Difference in insulin sensitivity
This will be measured by the disposition index. This will be calculated as the product of the AIRg and M value during the combined IVGTT and hyperinsulinaemic-euglycaemic clamp. This will be measured in a subset of patients (10 from each randomisation group), performed at baseline and on day 6 of dexamethasone and study medication.
Day 6
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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.
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Study Central Contact
Contact: Katharine Lazarus, MBChB, BSc, 07555717544, [email protected]
1 Study Locations in 1 Countries
Imperial College Healthcare NHS Trust, London, United Kingdom
Recruiting