Assessment of Colonic Motility in Patients With Diabetes Using High Resolution Colonic Manometry and 3D-Transit.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- High amplitude, antegrade contractions assessed with HRCM
研究概览
简要总结
Background:
Gastrointestinal (GI) symptoms are overrepresented in patients with diabetes mellitus (DM) and often have a major impact on quality of life. Typical symptoms of diabetic enteropathy include abdominal pain, nausea, vomiting, diarrhoea, constipation, faecal incontinence, and bloating. Bowel symptoms in DM are usually caused by widespread dysfunction of the GI tract, but the exact pathophysiology remains incompletely understood. Within recent years, new methods for detailed assessment of GI motility have been developed. Hence, the electromagnetic 3D-Transit system is a safe, non-invasive method for detailed description of GI motility. The system tracks the exact position of an ingested electromagnetic capsule through the entire GI tract and provides detailed information on both regional transit- and contraction patterns. High Resolution Colonic Manometry (HRCM) allows extremely detailed description of contraction patterns in the colon. The HRCM is however an invasive method, as the catheter is placed during colonoscopy. HRCM has not previously been performed on diabetic patients and 3D-Transit has only been used sparingly.
Study Objectives:
The purpose of this study is to obtain detailed description of colonic contractions in patients with DM and gastrointestinal symptoms, especially during fast and after meals.
Hypothesis:
- Patients with DM and GI symptoms have reduced high-amplitude, antegrade contractions in the colon when compared to healthy controls (HRCM).
- Patients with DM and GI symptoms have reduced long, fast mass-movements when compared to healthy controls (3D-Transit).
- The contractile response to a meal is reduced in patients with symptoms of diabetic enteropathy when compared to healthy controls.
Materials and methods:
20 patients with DM type 1 or 2 and GI symptoms will be investigated simultaneously HCRM and the 3D-Transit capsule. Data will be compared to the healthy from another study (CIV-19-05-028726). A colonoscopy is performed to install the HRCM catheter and place two 3D-Transit capsules within the colon. For 24 hours, the participants lie in a bed in the research lab while pressure changes from the HRCM catheter are recorded and the 3D-Transit capsules are followed through the gastrointestinal system.
Perspectives:
The study will add to the very limited data available on colonic dysfunction in DM.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or 2 diabetes (at least 3 years since diagnosis)
- •Age between 18 and 70
- •Gastrointestinal symptoms with a weighted and combined symptomscore >2,3 (assessed with The Gastrointestinal Symptom Rating Scale and The Gastroparesis Cardinal Symptom Score).
- •Psychologically able to give an informed content.
排除标准
- •Known gastrointestinal disease
- •Intake of medication with known effects on the motility patterns in the gastrointestinal system.
- •Dysregulated hyperthyroidism or hypothyroidism.
- •Any disease known to cause gastroparesis (Parkinson's disease, scleroderma, etc.)
- •Pacemaker/ICD
- •A scheduled MRI scan within 4 weeks after trial initiation.
- •Abdominal circumference >140cm
- •Pregnancy and lactation
- •Unable to follow the scheduled program in the trial due to mental illness or instability.
结局指标
主要结局
High amplitude, antegrade contractions assessed with HRCM
时间窗: All 24 hours of HRCM and 3D-Transit recording
Quantity, amplitude and duration of the high amplitude, antegrade propagating contractions accessed with HRCM, when compared to healthy controls.
次要结局
- Long, fast mass-movements assessed with 3D-Transit(All 24 hours of HRCM and 3D-Transit recording.)
- Distance of capsule movement.(All 24 hours of HRCM and 3D-Transit recording.)