Whole Gut Motility Abnormalities Following GLP-1 Receptor Agonist (GLP-1RA) Initiation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient reported outcome for gastroparesis symptoms as assessed by Gastroparesis Cardinal Symptom Index (GCSI) Questionnaire
研究概览
简要总结
Participants will undergo evaluation with the Atmo capsule at two time points: at baseline before starting the GLP-1RA or dual agonist therapy and after the subject has been taking their GLP-1RA or dual agonist therapy for 3 months. The total expected time for patient participation is up to 4 months from the time they start their GLP-1RA or dual agonist therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult patients (18 years or older)
- •Initiating GLP-1RA or GLP-1RA/GIP (dual agonist) therapy, or off GLP-1RA or GLP1-RA/GIP therapy for greater than 3 months for the treatment of type 2 diabetes with or without obesity (BMI > 30 kg/m2) at the time of the baseline visit
- •Stable glucose control (HbA1c ≤ 9%) within 6 months of the baseline visit
- •Normal TSH within 6 months of baseline visit
排除标准
- •Current use of opiates, marijuana, anticholinergics, or pro-motility medications. Can be included if there is no utilization for at least 1 month.
- •Use of antibiotics within the past 2 weeks
- •History of gastric or bowel surgery
- •Known or suspected history or active intestinal obstruction or stricture
- •Pregnancy
- •Patients for whom English is not their primary language will be excluded.
- •Cognitively impaired persons or other vulnerable populations who are unable to provide informed consent will be excluded.
结局指标
主要结局
Patient reported outcome for gastroparesis symptoms as assessed by Gastroparesis Cardinal Symptom Index (GCSI) Questionnaire
时间窗: At Baseline and 3 Month Follow Up
Patient-Reported Severity and Frequency of Gastrointestinal Symptoms as Assessed by Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire
时间窗: At Baseline and 3 Month Follow Up
Patient-Reported frequency, duration, and diagnostic criteria for conditions affecting the gastrointestinal tract for colonic motility and function as Assessed by Rome IV Diagnostic Questionnaire
时间窗: At Baseline and 3 Month Follow Up
次要结局
未报告次要终点
研究者
Samita Garg
Associate Professor of Medicine
The Cleveland Clinic