Assessment of Gastric Function Using Body Surface Gastric Mapping in Patients on Semaglutide (Ozempic)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- 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).
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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
排除标准
- •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.
研究组 & 干预措施
Semaglutide
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
干预措施: Gastric Alimetry (Device)
结局指标
主要结局
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).
时间窗: 3 months
Change in Overall BSGM BMI-adjusted Amplitude on Drug Compared to Baseline.
时间窗: 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.
次要结局
- Change in 5-level EQ-5D (minimum: 0; maximum: 1) scores on treatment compared to baseline (with a lower score meaning worse outcome).(3 months.)
- Correlation of postprandial BSGM Gastric Alimetry Rhythm Index (minimum: 0; maximum: 1) with symptom score (with a higher correlation meaning worse outcome).(3 months.)
- Change in Gastroparesis Cardinal Symptom Index (minimum: 0; maximum: 5) scores on treatment compared to baseline (with a higher score meaning worse outcome).(3 months)
- Change in Patient Health Questionnaire -8 (minimum: 0; maximum: 24) scores on treatment compared to baseline (with a higher score meaning worse outcome).(3 months.)
- 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).(3 months.)
- 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).(3 months)
- Change in General Anxiety Disorder-7 (minimum: 0; maximum: 21) scores on treatment compared to baseline (with a higher score meaning worse outcome).(3 months.)
- Change in Perceived Stress Scale-4 (minimum: 0; maximum: 4) scores on treatment compared to baseline (with a higher score meaning worse outcome).(3 months.)
- Change in Overall BSGM Principal Gastric Frequency on Drug Compared to Baseline.(Baseline, Month 2 (On Drug))
- Change in Overall BSGM Gastric Alimetry Rhythm Index on Drug Compared to Baseline.(Baseline, Month 2 (On Drug))
- Change in Overall BSGM Fed:Fasted Amplitude Ratio on Drug Compared to Baseline.(Baseline, Month 2 (On Drug))
- Change in Overall BSGM Meal Response Ratio on Drug Compared to Baseline.(Baseline, Month 2 (On Drug))
- Change in Total Symptom Burden Score on Drug Compared to Baseline.(Baseline, 2 Months (On Drug))
- Change in Total Gastroparesis Cardinal Symptom Index (GCSI) Score on Drug Compared to Baseline.(Baseline, 2 Months (On Drug))
- Change in Total Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Score on Drug Compared to Baseline.(Baseline, 2 Months (On Drug))
- 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))
研究者
Vincent Ho
Associate Professor
University of Western Sydney