Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery

Study Overview
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Brief Summary
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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.

Official Title
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European Dumping Study: Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery

Conditions
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Post Prandial Hypoglycemia

Intervention / Treatment
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* Diagnostic Test: Post Prandial Hypoglycemia test


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric Bypass Surgery population<br>liquid mixed meal tolerance test, solid mixed meal tolerance test, continuous glucose monitoring | Diagnostic Test: Post Prandial Hypoglycemia test<br>* three test assessing hypoglycemia will be used: liquid mixed meal tolerance test, solid mixed meal tolerances test, continuous glucose monitoring<br>|
| Control population<br>liquid mixed meal tolerance test, solid mixed meal tolerance test, continuous glucose monitoring | Diagnostic Test: Post Prandial Hypoglycemia test<br>* three test assessing hypoglycemia will be used: liquid mixed meal tolerance test, solid mixed meal tolerances test, continuous glucose monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | end 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | end 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roux en Y Gastric Bypass Surgery, Hypoglycemia, Postprandial