Fat Supplementation on Dumping Syndrome Related Symptoms After Gastric Surgery

NCT ID: NCT05759689

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dumping Syndrome Gastric Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Diagnose Dumping after supplement consumption

Carbohydrate ingestion to provoke dumping syndrome related symptoms

Group Type EXPERIMENTAL

Dietary Supplement: Resource Energy

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate Supplement

Dietary Supplement: Calogen

Intervention Type DIETARY_SUPPLEMENT

Polyunsaturated liquid fat supplement

Fat supplementation

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

Group Type ACTIVE_COMPARATOR

Dietary Supplement: Resource Energy

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate Supplement

Dietary Supplement: Calogen

Intervention Type DIETARY_SUPPLEMENT

Polyunsaturated liquid fat supplement

Interventions

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Dietary Supplement: Resource Energy

Carbohydrate Supplement

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Calogen

Polyunsaturated liquid fat supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Larissa University Hospital

OTHER

Sponsor Role lead

Responsible Party

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ATHANASIOS MIGDANIS

Research Associate Univeristy of Thessaly

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Larissa

Larissa, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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ATHANASIOS MIGDANIS

Role: CONTACT

6973240203

Facility Contacts

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ATHANASIOS MIGDANIS

Role: primary

6973240203

Other Identifiers

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LarissaUGH

Identifier Type: -

Identifier Source: org_study_id

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