Dumping SyndromeFat on DSNCT04028193
Fat Supplementation on Dumping Syndrome Associated Symptoms
A study testing Calogen and Resource Energy in people with Dumping Syndrome, run by Technological Educational Institute of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dumping Syndrome
- What is being tested?
- Calogen and Resource Energy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGreece
- Study dates
- 12 Sep 2017to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Dumping Syndrome
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Nikoleta Chatzipapa
Thessaloniki, 56533
NIKOLETA CHATZIPAPA, nikoletaxatzhpapa@hotmail.com
DEMETRA HARITOU, dharitou@yahoo.gr
About this study
Official title: 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.
- Conditions
- Dumping Syndrome
- Being tested
- Calogen, Resource Energy
- Keywords
- Dumping syndrome, Fat supplement, post bariatric surgery
- Medical subject headings
- Dumping Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalogenDietary supplement
Also called Calogen fat supplement
Polyunsaturated liquid fat supplement
Resource EnergyDietary supplement
Carbohydrate Supplement
| Study group | Role | What they receive |
|---|---|---|
| Diagnose Dumping after supplement consumption | Other | Carbohydrate ingestion to provoke dumping syndrome related symptoms Receives: Dietary Supplement: Resource Energy |
| Fat supplementation | Other | A high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis. Receives: Dietary Supplement: Calogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Levels
Blood glucose measurement
Measured: before the ingestion of the carbohydrate and fat supplement (baseline)
Glucose Levels
Blood glucose measurement
Measured: 30 minutes after the ingestion of the carbohydrate and fat supplement
Glucose Levels
Blood glucose measurement
Measured: 60 minutes after the ingestion of the the carbohydrate and fat supplement
Glucose Levels
Blood glucose measurement
Measured: 90 minutes after the ingestion of the the carbohydrate and fat supplement
Glucose Levels
Blood glucose measurement
Measured: 120 minutes after the ingestion of the the carbohydrate and fat supplement
Sigstad's Questionnaire
Dumping syndrome symptom associated questionnaire
Measured: 1st hour after the ingestion of the supplements
Sigstad's Questionnaire
Dumping syndrome symptom associated questionnaire
Measured: 2nd hour after the ingestion of the supplements
Arts's Questionnaire
Dumping syndrome symptom associated questionnaire
Measured: 1st hour after the ingestion of the supplements
Arts's Questionnaire
Dumping syndrome symptom associated questionnaire
Measured: 2nd hour after the ingestion of the supplements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start12 Sep 2017
- Primary completionDec 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dumping SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technological Educational Institute of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chatzipapa Nikoleta, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028193
- Sponsor's protocol ID
- 5411069DD0467
- Acronym
- Fat on DS
- Status last verified
- Nov 2022
- First submitted
- 15 Jul 2019
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fat Supplementation on the Appearance of Symptoms Associated With Dumping Syndrome in Patients Undergone Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04028193
- Acronym / sponsor ID
- Fat on DS / 5411069DD0467
- Conditions
- Dumping Syndrome
- Keywords
- Dumping syndrome, Fat supplement, post bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Technological Educational Institute of ThessalyUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnose Dumping after supplement consumption | Other | Dietary Supplement: Resource EnergyCarbohydrate ingestion to provoke dumping syndrome related symptoms |
| Fat supplementation | Other | Dietary Supplement: CalogenA high fat supplement was added to the carbohydrate liquid meal that was previously used for diagnosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Dumping Syndrome
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalogenAlso: Calogen fat supplementPolyunsaturated liquid fat supplement | Dietary supplement | Fat supplementation |
| Resource EnergyCarbohydrate Supplement | Dietary supplement | Diagnose Dumping after supplement consumption |
Primary outcome
Glucose Levels
Time frame: before the ingestion of the carbohydrate and fat supplement (baseline)
Blood glucose measurement
Glucose Levels
Time frame: 30 minutes after the ingestion of the carbohydrate and fat supplement
Blood glucose measurement
Glucose Levels
Time frame: 60 minutes after the ingestion of the the carbohydrate and fat supplement
Blood glucose measurement
Glucose Levels
Time frame: 90 minutes after the ingestion of the the carbohydrate and fat supplement
Blood glucose measurement
Glucose Levels
Time frame: 120 minutes after the ingestion of the the carbohydrate and fat supplement
Blood glucose measurement
Sigstad's Questionnaire
Time frame: 1st hour after the ingestion of the supplements
Dumping syndrome symptom associated questionnaire
Sigstad's Questionnaire
Time frame: 2nd hour after the ingestion of the supplements
Dumping syndrome symptom associated questionnaire
Arts's Questionnaire
Time frame: 1st hour after the ingestion of the supplements
Dumping syndrome symptom associated questionnaire
Arts's Questionnaire
Time frame: 2nd hour after the ingestion of the supplements
Dumping syndrome symptom associated questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calogen and Resource Energy in people with Dumping Syndrome, run by Technological Educational Institute of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NIKOLETA CHATZIPAPA (00306982484394, nikoletaxatzhpapa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Levels (time frame: before the ingestion of the carbohydrate and fat supplement (baseline)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.