Fat Supplementation on Dumping Syndrome Related Symptoms After Gastric Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Dumping Syndrome, Gastric Surgery

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement: Resource Energy
* Dietary Supplement: Dietary Supplement: Calogen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Dumping Syndrome Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnose Dumping after supplement consumption<br>Carbohydrate ingestion to provoke dumping syndrome related symptoms | Dietary Supplement: Dietary Supplement: Resource Energy<br>* Carbohydrate Supplement<br>Dietary Supplement: Dietary Supplement: Calogen<br>* Polyunsaturated liquid fat supplement<br>|
| Active Comparator: Fat supplementation<br>A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis. | Dietary Supplement: Dietary Supplement: Resource Energy<br>* Carbohydrate Supplement<br>Dietary Supplement: Dietary Supplement: Calogen<br>* Polyunsaturated liquid fat supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Levels | Blood glucose measurement | before the ingestion of the carbohydrate and fat supplement (baseline) | 
| Glucose Levels | Blood glucose measurement | 30 minutes after the ingestion of the carbohydrate and fat supplement | 
| Glucose Levels | Blood glucose measurement | 60 minutes after the ingestion of the the carbohydrate and fat supplement | 
| Glucose Levels | Blood glucose measurement | 90 minutes after the ingestion of the the carbohydrate and fat supplement | 
| Glucose Levels | Blood glucose measurement | 120 minutes after the ingestion of the the carbohydrate and fat supplement | 
| Sigstad's Questionnaire | Dumping syndrome symptom associated questionnaire | 1st hour after the ingestion of the supplements | 
| Sigstad's Questionnaire | Dumping syndrome symptom associated questionnaire | 2nd hour after the ingestion of the supplements | 
| Arts's Questionnaire | Dumping syndrome symptom associated questionnaire | 1st hour after the ingestion of the supplements | 
| Arts's Questionnaire | Dumping syndrome symptom associated questionnaire | 2nd hour after the ingestion of the supplements | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dumping syndrome, Fat supplement, Gastric surgery