Fat Supplementation on Dumping Syndrome Associated Symptoms (Fat on DS)
Primary Purpose
Dumping Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Calogen
Resource Energy
Sponsored by
About this trial
This is an interventional prevention trial for Dumping Syndrome focused on measuring Dumping syndrome, Fat supplement, post bariatric 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
- Nikoleta ChatzipapaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
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
NCT04028193
First Posted
July 15, 2019
Last Updated
November 12, 2022
Sponsor
Technological Educational Institute of Thessaly
1. Study Identification
Unique Protocol Identification Number
NCT04028193
Brief Title
Fat Supplementation on Dumping Syndrome Associated Symptoms
Acronym
Fat on DS
Official Title
The Effect of Fat Supplementation on the Appearance of Symptoms Associated With Dumping Syndrome in Patients Undergone Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technological Educational Institute of Thessaly
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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
Keywords
Dumping syndrome, Fat supplement, post bariatric surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnose Dumping after supplement consumption
Arm Type
Other
Arm Description
Carbohydrate ingestion to provoke dumping syndrome related symptoms
Arm Title
Fat supplementation
Arm Type
Other
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)
Calogen
Other Intervention Name(s)
Calogen fat supplement
Intervention Description
Polyunsaturated liquid fat supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Resource Energy
Intervention Description
Carbohydrate 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
NIKOLETA CHATZIPAPA
Phone
00306982484394
Email
nikoletaxatzhpapa@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
DEMETRA HARITOU
Phone
00306973240203
Email
dharitou@yahoo.gr
Facility Information:
Facility Name
Nikoleta Chatzipapa
City
Thessaloniki
ZIP/Postal Code
56533
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NIKOLETA CHATZIPAPA
Email
nikoletaxatzhpapa@hotmail.com
First Name & Middle Initial & Last Name & Degree
DEMETRA HARITOU
Email
dharitou@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Demetra Haritou
First Name & Middle Initial & Last Name & Degree
Nikoleta Chatzipapa
12. IPD Sharing Statement
Learn more about this trial
Fat Supplementation on Dumping Syndrome Associated Symptoms
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