Skip to main content
OpenTrials
Completed

NCT Number: NCT03406312

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Prandial Hypoglycemia Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinology, UZ Ghent Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Post Prandial Hypoglycemia test

Diagnostic Test

three test assessing hypoglycemia will be used: liquid mixed meal tolerance test, solid mixed meal tolerances test, continuous glucose monitoring

Primary outcomes

  1. Association between Sigstad's score and the lowest postprandial glucose levels

    Time frame: end 2018

    we are investigating whether there is an association between the Sigtad's score and the lowest glucose levels postprandialy

Secondary outcomes

  1. Association between Ediinburgh Hypoglycemia scale and the lowest postprandial glucose levels

    Time frame: end 2018

    we are investigating whether there is an association between the Ediinburgh Hypoglycemia scale and the lowest glucose levels postprandialy

  2. flow chart for diagnosis of postprandial reactive hypoglyceamia

    Time frame: end 2018

    Proposing a flowchart/diagnostic method for the diagnosis of postprandial reactive hypoglycemic syndrome which occurs in people who underwent a gastric bypass surgery

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Acronym: EDS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.