Post Prandial HypoglycemiaEDSNCT03406312
Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery
An observational study of Post Prandial Hypoglycemia, run by University Ghent at 1 site in Belgium.
Trial summary
Roux-en-Y gastric bypass (RYGB) leads to weight reduction but has also some unwanted side effects. A part of this population will develop postprandial reactive hypoglycemia (PPRH). At this moment no validated diagnostic tool exists for PPRH. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Prandial Hypoglycemia
- What is being tested?
- Post Prandial Hypoglycemia test
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2017to 5 May 2020
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In total 100 GBS patients which will be recruited over multiple sites in Germany, Great Britain, Belgium and Denmark. Belgium will be the only site performing the solid mixed meal tolerance test and the continuous glucose monitoring additional to the liquid mixed meal tolerance test. All other sites will only do the liquid mixed meal tolerance test. In total 20 control patients (10 with a BMI 18-25 kg/m² and 10 with a BMI > 30 kg/m²) will be recruited. These will be recruited in Belgium (Ghent University Hospital) and the patients will undergo a liquid mixed meal tolerance test, a solid mixed meal tolerance test and a continuous glucose monitoring
Who may be able to join
- for GBS group: primary GBS, 1-5 years post surgery
- for control group: 10 subjects BMI 18-25kg/m² and 10 subjects BMI >30 kg/m²
Who cannot join
- Antidiabetic medication (oral or injectable), somatostatin analogs
- Use of systemic corticosteroids
- for GBS group: Any surgery after RYGB affecting anatomic integrity of the bypass, e.g. banding, conversion of the proximal and/or distal anastomosis
- for GBS group: Any surgery before RYGB affecting anatomic integrity of the bypass, e.g. banding, conversion of the proximal and/or distal anastomosis, sleeve gastrectomy
- Known renal insufficiency: CDK ≥ 4
- Known liver cirrhosis
Show all 14Show fewer
- Known cardiovascular risk: NYHA ≥ III
- Mental incapacity
- Language barriers with inability to communicate with research staff
- Anemia Hb < 6.2 mmol/l (10.0 g/dl)
- Cancer within < 5 years
- Pregnancy
- Allergy to the Fresubin E
- Allergy to components of the solid mixed meal (white bread, cheese spread, margarine, orange)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: European Dumping Study: Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery
Roux-en-Y gastric bypass (RYGB) leads to weight reduction but has also some unwanted side effects. A part of this population will develop postprandial reactive hypoglycemia (PPRH). At this moment no validated diagnostic tool exists for PPRH. The aim of this study is to prove an association between the Sigstad´s Score and the lowest postprandial glucose level in patients after RYGB surgery. This is investigated using a liquid mixed meal tolerance test (LMMTT). As a secondary hypothesis, associations between Edinburgh Hypoglycemia Scale (EHS) and postprandial glucose levels are investigated. Furthermore, changes of insulin and GLP-1 levels during the test are analysed. Patient characteristics including co-morbidities are studied as possible influencing parameters. Moreover, a healthy control group is included to validate the results. Finally, a flowchart/diagnostic method will be proposed for diagnosing patients who had a RYBG surgery with symptoms suggestive of PPRH. Besides the LMMTT, participants at the Ghent University Hospital will undergo additional tests such as a solid mixed meal tolerance test (SMMTT) and continuous glucose monitoring (CGM). Associations between Sigstad Score, EHS and the lowest glucose measured during CGM and SMMTT will be investigated and compared to the results of the LMMTT.
- Conditions
- Post Prandial Hypoglycemia
- Being tested
- Post Prandial Hypoglycemia test
- Keywords
- Roux en Y Gastric Bypass Surgery, Hypoglycemia, Postprandial
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Prandial Hypoglycemia testDiagnostic test
three test assessing hypoglycemia will be used: liquid mixed meal tolerance test, solid mixed meal tolerances test, continuous glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass Surgery population | liquid mixed meal tolerance test, solid mixed meal tolerance test, continuous glucose monitoring Receives: Diagnostic Test: Post Prandial Hypoglycemia test | |
| Control population | liquid mixed meal tolerance test, solid mixed meal tolerance test, continuous glucose monitoring Receives: Diagnostic Test: Post Prandial Hypoglycemia test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between Sigstad's score and the lowest postprandial glucose levels
we are investigating whether there is an association between the Sigtad's score and the lowest glucose levels postprandialy
Measured: end 2018
Secondary outcomes (2)
Association between Ediinburgh Hypoglycemia scale and the lowest postprandial glucose levels
we are investigating whether there is an association between the Ediinburgh Hypoglycemia scale and the lowest glucose levels postprandialy
Measured: end 2018
flow chart for diagnosis of postprandial reactive hypoglyceamia
Proposing a flowchart/diagnostic method for the diagnosis of postprandial reactive hypoglycemic syndrome which occurs in people who underwent a gastric bypass surgery
Measured: end 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jun 2017
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Prandial HypoglycemiaStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406312
- Sponsor's protocol ID
- B670201731703
- Acronym
- EDS
- Status last verified
- Nov 2021
- First submitted
- 12 Jan 2018
- Last updated
- 1 Dec 2021
- 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 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Dumping Study: Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT03406312
- Acronym / sponsor ID
- EDS / B670201731703
- Conditions
- Post Prandial Hypoglycemia
- Keywords
- Roux en Y Gastric Bypass Surgery, Hypoglycemia, Postprandial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 23 Jan 2018 (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.
Roux-en-Y gastric bypass (RYGB) leads to weight reduction but has also some unwanted side effects. A part of this population will develop postprandial reactive hypoglycemia (PPRH). At this moment no validated diagnostic tool exists for PPRH. The aim of this study is to prove an association between the Sigstad´s Score and the lowest postprandial glucose level in patients after RYGB surgery. This is investigated using a liquid mixed meal tolerance test (LMMTT). As a secondary hypothesis, associations between Edinburgh Hypoglycemia Scale (EHS) and postprandial glucose levels are investigated. Furthermore, changes of insulin and GLP-1 levels during the test are analysed. Patient characteristics including co-morbidities are studied as possible influencing parameters. Moreover, a healthy control group is included to validate the results. Finally, a flowchart/diagnostic method will be proposed for diagnosing patients who had a RYBG surgery with symptoms suggestive of PPRH. Besides the LMMTT, participants at the Ghent University Hospital will undergo additional tests such as a solid mixed meal tolerance test (SMMTT) and continuous glucose monitoring (CGM). Associations between Sigstad Score, EHS and the lowest glucose measured during CGM and SMMTT will be investigated and compared to the results of the LMMTT.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass Surgery population | – | Diagnostic Test: Post Prandial Hypoglycemia testliquid mixed meal tolerance test, solid mixed meal tolerance test, continuous glucose monitoring |
| Control population | – | Diagnostic Test: Post Prandial Hypoglycemia testliquid mixed meal tolerance test, solid mixed meal tolerance test, continuous glucose monitoring |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In total 100 GBS patients which will be recruited over multiple sites in Germany, Great Britain, Belgium and Denmark. Belgium will be the only site performing the solid mixed meal tolerance test and the continuous glucose monitoring additional to the liquid mixed meal tolerance test. All other sites will only do the liquid mixed meal tolerance test. In total 20 control patients (10 with a BMI 18-25 kg/m² and 10 with a BMI > 30 kg/m²) will be recruited. These will be recruited in Belgium (Ghent University Hospital) and the patients will undergo a liquid mixed meal tolerance test, a solid mixed meal tolerance test and a continuous glucose monitoring
Key inclusion criteria (2 listed)
- for GBS group: primary GBS, 1-5 years post surgery
- for control group: 10 subjects BMI 18-25kg/m² and 10 subjects BMI >30 kg/m²
Key exclusion criteria (14 listed)
- Antidiabetic medication (oral or injectable), somatostatin analogs
- Use of systemic corticosteroids
- for GBS group: Any surgery after RYGB affecting anatomic integrity of the bypass, e.g. banding, conversion of the proximal and/or distal anastomosis
- for GBS group: Any surgery before RYGB affecting anatomic integrity of the bypass, e.g. banding, conversion of the proximal and/or distal anastomosis, sleeve gastrectomy
- Known renal insufficiency: CDK ≥ 4
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 |
|---|---|---|
| Post Prandial Hypoglycemia testthree test assessing hypoglycemia will be used: liquid mixed meal tolerance test, solid mixed meal tolerances test, continuous glucose monitoring | Diagnostic test | Control population, Gastric Bypass Surgery population |
Primary outcome
Association between Sigstad's score and the lowest postprandial glucose levels
Time frame: end 2018
we are investigating whether there is an association between the Sigtad's score and the lowest glucose levels postprandialy
2 secondary outcomes
Association between Ediinburgh Hypoglycemia scale and the lowest postprandial glucose levels
Time frame: end 2018
flow chart for diagnosis of postprandial reactive hypoglyceamia
Time frame: end 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
Related trials for Post Prandial Hypoglycemia
RecruitingPhase 4
Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH)
Hypoglycemia, Hypoglycemia, Reactive
RecruitingPhase 4
The Postprandial Hypo-Avoid Study
Type 1 Diabetes Mellitus
Not yet recruitingPhase 2
Anakinra for the Treatment of Postprandial Hypoglycemia in a Patient With Total Gastrectomy and End-Stage Renal Disease
Postprandial Hypoglycemia, End-stage Renal Disease (ESRD)
Active, not recruitingPhase 4
Glucagon Dose-Response in Patients With Post-Bariatric Hypoglycemia
Hypoglycemia, Hypoglycemia, Reactive
Recruiting
Dumping Syndrome and Esophageal Atresia
Oesophageal Atresia, Dumping Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Prandial Hypoglycemia, run by University Ghent at 1 site in Belgium.
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 2 inclusion and 14 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: finished, as of the sponsor's last update on 1 Dec 2021. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between Sigstad's score and the lowest postprandial glucose levels (time frame: end 2018). 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 1 Dec 2021.