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

University Ghent

Status

Completed

Conditions

Post Prandial Hypoglycemia

Treatments

Diagnostic Test: Post Prandial Hypoglycemia test

Study type

Observational

Funder types

Other

Identifiers

NCT03406312

B670201731703

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)