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

November 12, 2022 updated by: Chatzipapa Nikoleta, Technological Educational Institute of Thessaly

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Thessaloniki, Greece, 56533
        • Recruiting
        • Nikoleta Chatzipapa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Demetra Haritou
        • Principal Investigator:
          • Nikoleta Chatzipapa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technological Educational Institute of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 12, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5411069DD0467

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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