跳至主要内容
临床试验/NCT04028193
NCT04028193招募中不适用

The Effect of Fat Supplementation on the Appearance of Symptoms Associated With Dumping Syndrome in Patients Undergone Bariatric Surgery

Technological Educational Institute of Thessaly2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
2
主要终点
Arts's Questionnaire

研究概览

简要总结

The purpose of the study is the investigation of the effect of fat supplement on gastric emptying rate and the appearance of symptoms of Dumping Syndrome in patients who have undergone gastrointestinal- duodenal surgery. Patients who have undergone bariatric surgery have been examined for the presence of the Dumping syndrome, with glucose measurements, the Sigstad's questionnaire and questionnaire of Arts. Patients diagnosed positive, reiterated the examination process in a second meeting consuming an extra fat supplement. The data obtained on the different appointments were compared between the two groups in a cross over design.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with Dumping Syndrome

排除标准

  • Patients with diabetes mellitus type 1 and 2, Patients with impaired balance of fluids and electrolytes, Patients on diuretics pills or corticosteroids or hypoglycemic tablets and Insulin.

结局指标

主要结局

Arts's Questionnaire

时间窗: 2nd hour after the ingestion of the supplements

Dumping syndrome symptom associated questionnaire

Glucose Levels

时间窗: 120 minutes after the ingestion of the the carbohydrate and fat supplement

Blood glucose measurement

Sigstad's Questionnaire

时间窗: 2nd hour after the ingestion of the supplements

Dumping syndrome symptom associated questionnaire

次要结局

未报告次要终点

研究者

发起方
Technological Educational Institute of Thessaly
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chatzipapa Nikoleta

Research Associate University of Thessaly

University of Thessaly

研究点 (2)

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