The Effect of Fat Supplementation on the Appearance of Symptoms Associated With Dumping Syndrome in Patients Undergone Bariatric Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 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
- 否
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.
研究组 & 干预措施
Fat supplementation
A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis.
干预措施: Calogen (Dietary Supplement)
Diagnose Dumping after supplement consumption
Carbohydrate ingestion to provoke dumping syndrome related symptoms
干预措施: Resource Energy (Dietary Supplement)
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
Glucose Levels
时间窗: before the ingestion of the carbohydrate and fat supplement (baseline)
Blood glucose measurement
Glucose Levels
时间窗: 30 minutes after the ingestion of the carbohydrate and fat supplement
Blood glucose measurement
Glucose Levels
时间窗: 60 minutes after the ingestion of the the carbohydrate and fat supplement
Blood glucose measurement
Glucose Levels
时间窗: 90 minutes after the ingestion of the the carbohydrate and fat supplement
Blood glucose measurement
Sigstad's Questionnaire
时间窗: 1st hour after the ingestion of the supplements
Dumping syndrome symptom associated questionnaire
Arts's Questionnaire
时间窗: 1st 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
Chatzipapa Nikoleta
Research Associate University of Thessaly
University of Thessaly