An observational study in Post Prandial Hypoglycemia, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-01.
Sponsored by University Ghent · Observational
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.
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
Exclusion Criteria:
liquid mixed meal tolerance test, solid mixed meal tolerance test, continuous glucose monitoring
Diagnostic Test: Post Prandial Hypoglycemia test
liquid mixed meal tolerance test, solid mixed meal tolerance test, continuous glucose monitoring
Diagnostic Test: Post Prandial Hypoglycemia test
three test assessing hypoglycemia will be used: liquid mixed meal tolerance test, solid mixed meal tolerances test, continuous glucose monitoring
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
Time frame: end 2018
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
Time frame: 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
Time frame: end 2018
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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University Ghent