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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05759689
Other study ID # LarissaUGH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 28, 2021
Est. completion date September 2024

Study information

Verified date March 2023
Source Larissa University Hospital
Contact ATHANASIOS MIGDANIS
Phone 6973240203
Email thanmig@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dietary Supplement: Resource Energy
Carbohydrate Supplement
Dietary Supplement: Calogen
Polyunsaturated liquid fat supplement

Locations

Country Name City State
Greece University Hospital Larissa Larissa

Sponsors (1)

Lead Sponsor Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose Levels Blood glucose measurement before the ingestion of the carbohydrate and fat supplement (baseline)
Primary Glucose Levels Blood glucose measurement 30 minutes after the ingestion of the carbohydrate and fat supplement
Primary Glucose Levels Blood glucose measurement 60 minutes after the ingestion of the the carbohydrate and fat supplement
Primary Glucose Levels Blood glucose measurement 90 minutes after the ingestion of the the carbohydrate and fat supplement
Primary Glucose Levels Blood glucose measurement 120 minutes after the ingestion of the the carbohydrate and fat supplement
Primary Sigstad's Questionnaire Dumping syndrome symptom associated questionnaire 1st hour after the ingestion of the supplements
Primary Sigstad's Questionnaire Dumping syndrome symptom associated questionnaire 2nd hour after the ingestion of the supplements
Primary Arts's Questionnaire Dumping syndrome symptom associated questionnaire 1st hour after the ingestion of the supplements
Primary Arts's Questionnaire Dumping syndrome symptom associated questionnaire 2nd hour after the ingestion of the supplements
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Completed NCT01923649 - SOMATULINE Autogel 90 mg IN DUMPING SYNDROME Phase 2