Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastri… (NCT03406312) | Clinical Trial Compass
CompletedNot Applicable
Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery
Belgium40 participantsStarted 2017-06-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association between Sigstad's score and the lowest postprandial glucose levels