NCT01607684已完成2 期
Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Frequency of gastric peristalsis
研究概览
简要总结
The purpose of this study is to determine whether Magnetic Marker Monitoring is an appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects with diabetic polyneuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 50 years
- •written informed consent
- •Diabetes mellitus (only Diabetes mellitus group)
- •Symptoms of diabetic gastroparesis with respect to nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire (only Diabetes mellitus group)
- •actually measured HbA1c (only Diabetes mellitus group)
排除标准
- •Subject who is pregnant or breast feeding.
- •Subject unwilling or unable to comply with study requirements.
- •Any investigational agent or participation in another clinical trial within 28 days prior to randomization
- •Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
- •History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
- •Known allergy to the investigational product, to any of its excipients
- •Active inflammatory bowel disease, serious gastric ulceration or other bowel diseases like e.g. coeliac disease
- •Implanted cardiac cardioverter-defibrillator or cardiac pacemaker
- •Stenosis or stricture of gastrointestinal tract or any surgery in this region except for cholecystectomy or appendectomy
- •Long-term medication with drug, that influence gastrointestinal motility (opiate, opioids, erythromycin, metoclopramide, laxatives) < 3 days before randomisation and before magnetic marker monitoring
研究组 & 干预措施
Diabetes mellitus group
Other
Subjects with Diabetes mellitus and symptoms of diabetic gastroparesis
干预措施: Magnetic Marker Imaging (MMI) with Magma 3D system (Device)
Control group
Other
Healthy volunteers as matched pairs according to gender and age
干预措施: Magnetic Marker Imaging (MMI) with Magma 3D system (Device)
结局指标
主要结局
Frequency of gastric peristalsis
时间窗: 4 hours
次要结局
- Intensity of gastric peristaltic waves(4 hours)
- Correlation with other parameters of diabetic polyneuropathy (nausea, postprandial fullness, abdominal pain, nausea, vomiting, abdominal bloating, early satiety, erratic blood glucose levels and weight loss evaluated by a standardized questionnaire)(4 hours)
- Influence of age on parameters of diabetic polyneuropathy measurable by magnetic marker imaging(4 hours)
研究者
Prof. Dr. med. Thomas Seufferlein
Prof. Dr. med.
Martin-Luther-Universität Halle-Wittenberg
研究点 (1)
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