Fat Supplementation on Dumping Syndrome Related Symptoms After Gastric Surgery
Primary Purpose
Dumping Syndrome, Gastric Surgery
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Dietary Supplement: Resource Energy
Dietary Supplement: Calogen
Sponsored by
About this trial
This is an interventional prevention trial for Dumping Syndrome focused on measuring Dumping syndrome, Fat supplement, Gastric surgery
Eligibility Criteria
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.
Sites / Locations
- University Hospital LarissaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diagnose Dumping after supplement consumption
Fat supplementation
Arm Description
Carbohydrate ingestion to provoke dumping syndrome related symptoms
A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis.
Outcomes
Primary Outcome Measures
Glucose Levels
Blood glucose measurement
Glucose Levels
Blood glucose measurement
Glucose Levels
Blood glucose measurement
Glucose Levels
Blood glucose measurement
Glucose Levels
Blood glucose measurement
Sigstad's Questionnaire
Dumping syndrome symptom associated questionnaire
Sigstad's Questionnaire
Dumping syndrome symptom associated questionnaire
Arts's Questionnaire
Dumping syndrome symptom associated questionnaire
Arts's Questionnaire
Dumping syndrome symptom associated questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT05759689
First Posted
February 26, 2023
Last Updated
March 19, 2023
Sponsor
Larissa University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05759689
Brief Title
Fat Supplementation on Dumping Syndrome Related Symptoms After Gastric Surgery
Official Title
The Effect of Fat Supplementation on the Appearance of Symptoms Associated With Dumping Syndrome in Patients Undergone Gastric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larissa University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dumping Syndrome, Gastric Surgery
Keywords
Dumping syndrome, Fat supplement, Gastric surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnose Dumping after supplement consumption
Arm Type
Experimental
Arm Description
Carbohydrate ingestion to provoke dumping syndrome related symptoms
Arm Title
Fat supplementation
Arm Type
Active Comparator
Arm Description
A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: Resource Energy
Intervention Description
Carbohydrate Supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: Calogen
Intervention Description
Polyunsaturated liquid fat supplement
Primary Outcome Measure Information:
Title
Glucose Levels
Description
Blood glucose measurement
Time Frame
before the ingestion of the carbohydrate and fat supplement (baseline)
Title
Glucose Levels
Description
Blood glucose measurement
Time Frame
30 minutes after the ingestion of the carbohydrate and fat supplement
Title
Glucose Levels
Description
Blood glucose measurement
Time Frame
60 minutes after the ingestion of the the carbohydrate and fat supplement
Title
Glucose Levels
Description
Blood glucose measurement
Time Frame
90 minutes after the ingestion of the the carbohydrate and fat supplement
Title
Glucose Levels
Description
Blood glucose measurement
Time Frame
120 minutes after the ingestion of the the carbohydrate and fat supplement
Title
Sigstad's Questionnaire
Description
Dumping syndrome symptom associated questionnaire
Time Frame
1st hour after the ingestion of the supplements
Title
Sigstad's Questionnaire
Description
Dumping syndrome symptom associated questionnaire
Time Frame
2nd hour after the ingestion of the supplements
Title
Arts's Questionnaire
Description
Dumping syndrome symptom associated questionnaire
Time Frame
1st hour after the ingestion of the supplements
Title
Arts's Questionnaire
Description
Dumping syndrome symptom associated questionnaire
Time Frame
2nd hour after the ingestion of the supplements
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ATHANASIOS MIGDANIS
Phone
6973240203
Email
thanmig@yahoo.com
Facility Information:
Facility Name
University Hospital Larissa
City
Larissa
ZIP/Postal Code
41334
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ATHANASIOS MIGDANIS
Phone
6973240203
Email
thanmig@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Fat Supplementation on Dumping Syndrome Related Symptoms After Gastric Surgery
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