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Fat Supplementation on Dumping Syndrome Associated Symptoms (Fat on DS)

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ClinicalTrials.gov Identifier: NCT04028193
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Chatzipapa Nikoleta, University of Thessaly

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.

Condition or disease Intervention/treatment Phase
Dumping Syndrome Dietary Supplement: Calogen Dietary Supplement: Resource Energy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Fat Supplementation on the Appearance of Symptoms Associated With Dumping Syndrome in Patients Undergone Bariatric Surgery
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Diagnose Dumping after supplement consumption
Carbohydrate ingestion to provoke dumping syndrome related symptoms
Dietary Supplement: Resource Energy
Carbohydrate Supplement

Fat supplementation
A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis.
Dietary Supplement: Calogen
Polyunsaturated liquid fat supplement
Other Name: Calogen fat supplement




Primary Outcome Measures :
  1. Glucose Levels [ Time Frame: before the ingestion of the carbohydrate and fat supplement (baseline) ]
    Blood glucose measurement

  2. Glucose Levels [ Time Frame: 30 minutes after the ingestion of the carbohydrate and fat supplement ]
    Blood glucose measurement

  3. Glucose Levels [ Time Frame: 60 minutes after the ingestion of the the carbohydrate and fat supplement ]
    Blood glucose measurement

  4. Glucose Levels [ Time Frame: 90 minutes after the ingestion of the the carbohydrate and fat supplement ]
    Blood glucose measurement

  5. Glucose Levels [ Time Frame: 120 minutes after the ingestion of the the carbohydrate and fat supplement ]
    Blood glucose measurement

  6. Sigstad's Questionnaire [ Time Frame: 1st hour after the ingestion of the supplements ]
    Dumping syndrome symptom associated questionnaire

  7. Sigstad's Questionnaire [ Time Frame: 2nd hour after the ingestion of the supplements ]
    Dumping syndrome symptom associated questionnaire

  8. Arts's Questionnaire [ Time Frame: 1st hour after the ingestion of the supplements ]
    Dumping syndrome symptom associated questionnaire

  9. Arts's Questionnaire [ Time Frame: 2nd hour after the ingestion of the supplements ]
    Dumping syndrome symptom associated questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028193


Contacts
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Contact: NIKOLETA CHATZIPAPA 00306982484394 nikoletaxatzhpapa@hotmail.com
Contact: DEMETRA HARITOU 00306973240203 dharitou@yahoo.gr

Locations
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Greece
Nikoleta Chatzipapa Recruiting
Thessaloniki, Greece, 56533
Contact: NIKOLETA CHATZIPAPA       nikoletaxatzhpapa@hotmail.com   
Contact: DEMETRA HARITOU       dharitou@yahoo.gr   
Principal Investigator: Demetra Haritou         
Principal Investigator: Nikoleta Chatzipapa         
Sponsors and Collaborators
Technological Educational Institute of Thessaly

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Responsible Party: Chatzipapa Nikoleta, Research Associate University of Thessaly, University of Thessaly
ClinicalTrials.gov Identifier: NCT04028193    
Other Study ID Numbers: 5411069DD0467
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chatzipapa Nikoleta, University of Thessaly:
Dumping syndrome
Fat supplement
post bariatric surgery
Additional relevant MeSH terms:
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Dumping Syndrome
Syndrome
Disease
Pathologic Processes
Postgastrectomy Syndromes
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications