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

Post Prandial Hypoglycemia Clinical Trial

— EDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406312
• Other study ID #: B670201731703
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: May 5, 2020

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypoglycemia
• Post Prandial Hypoglycemia

Intervention

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

Locations

Country	Name	City	State
Belgium	Endocrinology, UZ Ghent Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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