Gastroparesis, Semaglutide-Induced Gastric Motility
Conditions
Keywords
Semaglutide, GLP-1 Receptor Agonist, Gastric Motility, Body Surface Gastric Mapping
Brief summary
Glucagon-like receptor-1 agonists (GLP-1 RAs), such as Semaglutide (Ozempic), are a class of drugs used for glycemic control in diabetes, and for weight loss and management in obesity. It has been shown to delay gastric emptying and lead to gastrointestinal symptoms. However, the exact mechanisms are unknown. Alterations in gastric function, including myoelectrical activity, may be a likely mechanism of gastrointestinal side effects. Body Surface Gastric Mapping (BSGM) using the FDA-approved medical device Gastric Alimetry is a novel non-invasive diagnostic tool to assess gastric myoelectrical activity and patient-reported symptoms to achieve accurate non-invasive biomarkers of gastric dysfunction. A proof-of-principle case study of Ozempic using Gastric Alimetry showed abnormal gastric myoelectrical activity along with the development of severe bloating following the meal after 5 weeks of Ozempic use. This study will extend on this initial finding by conducting an exploratory pilot study to investigate the effects on gastric motility in patients with and without diabetes before and after Ozempic. It is hypothesized that Gastric Alimetry will show changes in gastric myoelectrical activity and symptoms in patients after being on the weekly injectable Ozempic compared to baseline.
Interventions
DEVICEGastric Alimetry
The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
Sponsors
University of Western Sydney
University of Auckland, New Zealand
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall BSGM BMI-adjusted Amplitude on Drug Compared to Baseline. | Baseline, Month 2 (On Drug) | Amplitude is a measure of the strength of contractions. It has a normative reference range between 22-70 microvolts; values outside this range indicate a worse outcome. Minimum: 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall BSGM Principal Gastric Frequency on Drug Compared to Baseline. | Baseline, Month 2 (On Drug) | The BSGM Principal Gastric Frequency is the number of slow waves in a minute and measured as cycles per minute (cpm). It has a normative reference range between 2.65-3.35 cpm; values outside this range indicate a worse outcome. Minimum: 0; maximum: 6. |
| Change in Overall BSGM Gastric Alimetry Rhythm Index on Drug Compared to Baseline. | Baseline, Month 2 (On Drug) | BSGM Gastric Alimetry Rhythm Index is a measure of stability; calculated as a single unitless value. A normal value is indicated as more than or equal to 0.25; a lower value indicates greater instability/worse outcomes. Minimum: 0; maximum: 1. |
| Change in Overall BSGM Fed:Fasted Amplitude Ratio on Drug Compared to Baseline. | Baseline, Month 2 (On Drug) | Fed:fasted amplitude ratio is the ratio of the maximum 1-hour averaged postprandial amplitude to the premeal average amplitude and calculated as a single value. A normal value is indicated as \>1.08; a higher value indicates a better outcome. Minimum: 0. |
| Change in Overall BSGM Meal Response Ratio on Drug Compared to Baseline. | Baseline, Month 2 (On Drug) | Meal response ratio is the ratio of the average amplitude in the first 2 hours postprandially to that of the last 2 hours and calculated as a single value. A normal meal response ratio is defined as \> 1; a higher value indicates a better outcome. Minimum: 0. |
| Change in Total Symptom Burden Score on Drug Compared to Baseline. | Baseline, 2 Months (On Drug) | Minimum: 0; maximum: 70. A total symptom burden score is calculated by the sum of the mean of each symptom score. A higher score indicates a worse outcome. |
| Change in Total Gastroparesis Cardinal Symptom Index (GCSI) Score on Drug Compared to Baseline. | Baseline, 2 Months (On Drug) | Minimum: 0; maximum: 5. The total GCSI score cover three subscales: nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), and bloating (2 items); calculated by taking the mean of the three individual subscale scores. A higher score indicates a worse outcome. |
| Change in Total Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Score on Drug Compared to Baseline. | Baseline, 2 Months (On Drug) | Minimum: 0; maximum: 5. The total PAGI-SYM score covers six subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items); calculated by taking the mean of the six individual subscale scores. A higher score indicates a worse outcome. |
| Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Fullness/Early Satiation Subscale on Drug Compared to Baseline. | Baseline, 2 Months (On Drug) | Minimum: 0; maximum: 5. The PAGI-SYM fullness/early satiation subscale covers post-prandial fullness/early satiety (4 items); calculated by taking the mean of the 4 items. A higher score indicates a worse outcome. |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORVincent Ho, MBBS, FRACP, FACP, PhD
Western Sydney University
Participant flow
Recruitment details
Patients aged ≥ 18 years, did not present with gastroduodenal symptoms and prescribed semaglutide as part of their standard care (for weight loss or diabetes) were recruited from a tertiary center.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55 Years |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
None listed