Clinical trial NCT03406312: Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery
Official title: European Dumping Study: Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Prandial Hypoglycemia
Keywords: Roux en Y Gastric Bypass Surgery, Hypoglycemia, Postprandial
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Association between Sigstad's score and the lowest postprandial glucose levels
timeFrame: end 2018
Secondary outcomes:
measure: Association between Ediinburgh Hypoglycemia scale and the lowest postprandial glucose levels
timeFrame: end 2018
measure: flow chart for diagnosis of postprandial reactive hypoglyceamia
timeFrame: end 2018
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Endocrinology, UZ Ghent Hospital
Study officials:
References: