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RecruitingPhase NA

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

How GLP-1 Analogues Prevent Steroid-Induced Diabetes

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Diabetes (other / unspecified), Prediabetes / glucose intolerance

Key I/E criterion

BMI ≥22.5

Primary endpoint

Postprandial glucose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06318442
Org study ID22HH8018

Timeline

Milestones

Study first posted2024-03-19actual
Study start2024-05-15actual
Last update posted2024-10-02actual
Primary completion2027-06-01estimated
Study completion2027-06-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Diabetes (other / unspecified)Prediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
8
Other (unclassified)
4
Weight & body composition
2
Cardiometabolic biomarkers
1

Weight & body composition

2 endpoints
Other/protocol endpoint

Changes in anthropometrics

Time frame:Through study completion, on day 7 dexamethasone and study medication

BMI, change

change from baseline, improvement

Other/protocol endpoint

Changes in anthropometrics

Time frame:Through study completion, on day 7 dexamethasone and study medication

change from baseline, improvement

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Difference in Glucose tolerance

Time frame:Through study completion, on day 7 dexamethasone and study medication

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Difference in insulin secretion

Time frame:Day 6 of dexamethasone and study medication

change from baseline, improvement

Secondary/protocol endpoint

Difference in insulin sensitivity

Time frame:Day 6

change from baseline, improvement

Secondary/protocol endpoint

Difference in insulin sensitivity

Time frame:Day 6

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Difference in insulin sensitivity

Time frame:Day 6

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Mean glucose and glycaemic variation by continuous glucose monitoring (CGM), using a validated blinded system (Dexcom G7).

Time frame:Through study completion

descriptive, improvement

Other/protocol endpoint

Changes in fasting gut hormones

Time frame:Through study completion, on day 7 dexamethasone and study medication

change from baseline, improvement

Other/protocol endpoint

Changes in post prandial gut hormones

Time frame:Through study completion, on day 7 dexamethasone and study medication

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Other/protocol endpoint

Changes in fasting lipid profile

Time frame:Through study completion, on day 7 dexamethasone and study medication

change from baseline, improvement

Other (unclassified)

4 endpoints
Other/protocol endpoint/low confidence

Changes in fasting gut hormones

Time frame:Through study completion, on day 7 dexamethasone and study medication

change from baseline, descriptive

Other/protocol endpoint/low confidence

Changes in fasting gut hormones

Time frame:Through study completion, on day 7 dexamethasone and study medication

change from baseline, descriptive

Other/protocol endpoint/low confidence

Changes in post prandial gut hormones

Time frame:Through study completion, on day 7 dexamethasone and study medication

change from baseline, descriptive

Other/protocol endpoint/low confidence

Tissue specific changes in AMPK determined from adipose and muscle biopsies

Time frame:Through study completion, on day 7 dexamethasone and study medication

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.