Fat Supplementation on Dumping Syndrome Associated Symptoms

Dumping Syndrome Clinical Trial

— Fat on DS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028193
• Other study ID #: 5411069DD0467
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: April 2023

Study information

• Verified date: November 2022
• Source: Technological Educational Institute of Thessaly
• Contact: NIKOLETA CHATZIPAPA
• Phone: 00306982484394
• Email: nikoletaxatzhpapa[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dumping Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Calogen
Polyunsaturated liquid fat supplement
• Resource Energy
Carbohydrate Supplement

Locations

Country	Name	City	State
Greece	Nikoleta Chatzipapa	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Technological Educational Institute of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

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