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

Plain-language guide to NCT06318442: not phased randomized trial of Semaglutide, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06318442
Phase
not phased
Status
recruiting participants
Start
2024-05-15
Completion (planned or actual)
2027-06-01
Participants
60 (estimated)
Design
randomized, quadruple-blind, basic_science
Conditions studied
Steroid-Induced Diabetes; Steroid Induced Hyperglycemia
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Semaglutide.

This is a mechanistic experimental medicine study.

It had three arms (groups): Once daily semaglutide (experimental), - Metformin (active comparator) and Placebo (placebo comparator).

Placebo tablets.

The registry classes the interventions as drug.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Adults ≥ 18 years;. Male or female;. Body mass index ≥22.5 kg/m2.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: 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);.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-05-15 with completion listed for 2027-06-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Difference in Glucose tolerance (time frame: Through study completion, on day 7 dexamethasone and study medication).

It also tracked 4 secondary outcomes, for example Difference in insulin secretion, Difference in insulin sensitivity, Difference in insulin sensitivity and Difference in insulin sensitivity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.