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

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

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.

Study Overview

• Status: Completed
• Conditions: Post Prandial Hypoglycemia
• Intervention / Treatment: Diagnostic test: Post Prandial Hypoglycemia test

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Endocrinology, UZ Ghent Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastric Bypass Surgery population; 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
Control population; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): May 5, 2020
• Study Completion (Actual): May 5, 2020

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Roux en Y Gastric Bypass Surgery, Hypoglycemia, Postprandial
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: B670201731703

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No