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Fat on DS: Fat Supplementation on Dumping Syndrome Associated Symptoms

Sponsor
Technological Educational Institute of Thessaly (Other)
Overall Status
Recruiting
CT.gov ID
NCT04028193
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
47.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Calogen
  • Dietary Supplement: Resource Energy
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 12, 2017
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Diagnose Dumping after supplement consumption

Carbohydrate ingestion to provoke dumping syndrome related symptoms

Dietary Supplement: Resource Energy
Carbohydrate Supplement
Other: 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 Names:
  • Calogen fat supplement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glucose Levels [before the ingestion of the carbohydrate and fat supplement (baseline)]

      Blood glucose measurement

    2. Glucose Levels [30 minutes after the ingestion of the carbohydrate and fat supplement]

      Blood glucose measurement

    3. Glucose Levels [60 minutes after the ingestion of the the carbohydrate and fat supplement]

      Blood glucose measurement

    4. Glucose Levels [90 minutes after the ingestion of the the carbohydrate and fat supplement]

      Blood glucose measurement

    5. Glucose Levels [120 minutes after the ingestion of the the carbohydrate and fat supplement]

      Blood glucose measurement

    6. Sigstad's Questionnaire [1st hour after the ingestion of the supplements]

      Dumping syndrome symptom associated questionnaire

    7. Sigstad's Questionnaire [2nd hour after the ingestion of the supplements]

      Dumping syndrome symptom associated questionnaire

    8. Arts's Questionnaire [1st hour after the ingestion of the supplements]

      Dumping syndrome symptom associated questionnaire

    9. Arts's Questionnaire [2nd hour after the ingestion of the supplements]

      Dumping syndrome symptom associated questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nikoleta Chatzipapa Thessaloniki Greece 56533

    Sponsors and Collaborators

    • Technological Educational Institute of Thessaly

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chatzipapa Nikoleta, Research Associate University of Thessaly, University of Thessaly
    ClinicalTrials.gov Identifier:
    NCT04028193
    Other Study ID Numbers:
    • 5411069DD0467
    First Posted:
    Jul 22, 2019
    Last Update Posted:
    Dec 4, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chatzipapa Nikoleta, Research Associate University of Thessaly, University of Thessaly
    Dumping syndrome
    Fat supplement
    post bariatric surgery
    Additional relevant MeSH terms:
    Dumping Syndrome
    Syndrome

    Study Results

    No Results Posted as of Dec 4, 2020