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Recruiting

Body Surface Gastric Mapping in Patients on Semaglutide

Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

1

Enrollment

15

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

HbA1c ≥7%

Primary endpoint

Overall postprandial BSGM Gastric Alimetry Rhythm Index on treatment compared

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 IDNCT06401746
Org study IDWS-GLP-001

Timeline

Milestones

Study start2024-05-01actual
Study first posted2024-05-07actual
Primary completion2025-03-13actual
Last update posted2025-03-26actual
Study completion2025-06-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodProbability sample

Study population text

Patients with or without Type 2 Diabetes Mellitus who are prescribed Semaglutide in a general metabolic clinic.

Inclusion criteria

>18 years old
No gastrointestinal symptoms based on Rome IV criteria
For diabetics: Diagnosed T2DM (defined as HbA1c levels > 7%)
For diabetics: Fasting blood glucose level < 15 mmol/L

Exclusion criteria

Current use of Ozempic, similar GLP-1 RAs or regular insulin in the last 3 months
Confirmed gastroparesis on gastric emptying scintigraphy
Pregnant or breast-feeding
Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.

Endpoints (9)

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

Patient-reported / QoL
7
Other clinical outcomes
2

Patient-reported / QoL

7 endpoints
Secondary/protocol endpoint

Change in Gastroparesis Cardinal Symptom Index (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a higher score meaning worse outcome).

Time frame:3 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a higher score meaning worse outcome).

Time frame:3 months

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a lower score meaning worse outcome).

Time frame:3 months.

change from baseline, improvement

Secondary/protocol endpoint

Change in 5-level EQ-5D (minimum: 0; maximum: 1) scores on treatment compared to baseline (with a lower score meaning worse outcome).

Time frame:3 months.

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Change in Patient Health Questionnaire -8 (minimum: 0; maximum: 24) scores on treatment compared to baseline (with a higher score meaning worse outcome).

Time frame:3 months.

change from baseline, improvement

Secondary/protocol endpoint

Change in General Anxiety Disorder-7 (minimum: 0; maximum: 21) scores on treatment compared to baseline (with a higher score meaning worse outcome).

Time frame:3 months.

change from baseline, improvement

Secondary/protocol endpoint

Change in Perceived Stress Scale-4 (minimum: 0; maximum: 4) scores on treatment compared to baseline (with a higher score meaning worse outcome).

Time frame:3 months.

change from baseline, improvement

Other clinical outcomes

2 endpoints
Primary/protocol endpoint/low confidence

Change in overall postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) on treatment compared to baseline (with a lower score meaning worse outcome).

Time frame:3 months

change from baseline, improvement

Secondary/protocol endpoint

Correlation of postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) with symptom score (with a higher correlation meaning worse outcome).

Time frame:3 months.

descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

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.