NCT04028193

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

5.2 years

First QC Date

July 15, 2019

Last Update Submit

November 12, 2022

Conditions

Dumping Syndrome

Keywords

Dumping syndromeFat supplementpost bariatric surgery

Outcome Measures

Primary Outcomes (9)

  • Glucose Levels

    Blood glucose measurement

    before the ingestion of the carbohydrate and fat supplement (baseline)

  • Glucose Levels

    Blood glucose measurement

    30 minutes after the ingestion of the carbohydrate and fat supplement

  • Glucose Levels

    Blood glucose measurement

    60 minutes after the ingestion of the the carbohydrate and fat supplement

  • Glucose Levels

    Blood glucose measurement

    90 minutes after the ingestion of the the carbohydrate and fat supplement

  • Glucose Levels

    Blood glucose measurement

    120 minutes after the ingestion of the the carbohydrate and fat supplement

  • Sigstad's Questionnaire

    Dumping syndrome symptom associated questionnaire

    1st hour after the ingestion of the supplements

  • Sigstad's Questionnaire

    Dumping syndrome symptom associated questionnaire

    2nd hour after the ingestion of the supplements

  • Arts's Questionnaire

    Dumping syndrome symptom associated questionnaire

    1st hour after the ingestion of the supplements

  • Arts's Questionnaire

    Dumping syndrome symptom associated questionnaire

    2nd hour after the ingestion of the supplements

Study Arms (2)

Diagnose Dumping after supplement consumption

OTHER

Carbohydrate ingestion to provoke dumping syndrome related symptoms

Dietary Supplement: Resource Energy

Fat supplementation

OTHER

A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis.

Dietary Supplement: Calogen

Interventions

CalogenDIETARY_SUPPLEMENT

Polyunsaturated liquid fat supplement

Also known as: Calogen fat supplement
Fat supplementation
Resource EnergyDIETARY_SUPPLEMENT

Carbohydrate Supplement

Diagnose Dumping after supplement consumption

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Dumping Syndrome

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nikoleta Chatzipapa

Thessaloniki, 56533, Greece

RECRUITING

MeSH Terms

Conditions

Dumping Syndrome

Interventions

Energy-Generating Resources

Condition Hierarchy (Ancestors)

Postgastrectomy SyndromesStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EnvironmentEnvironment and Public Health

Central Study Contacts

NIKOLETA CHATZIPAPA

CONTACT

00306982484394nikoletaxatzhpapa@hotmail.com

DEMETRA HARITOU

CONTACT

00306973240203dharitou@yahoo.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate University of Thessaly

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 22, 2019

Study Start

September 12, 2017

Primary Completion

December 1, 2022

Study Completion

April 1, 2023

Last Updated

November 15, 2022

Record last verified: 2022-11

Locations

GR(1)