MedDataX Logo

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

NCT ID: NCT03406312

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-05-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Prandial Hypoglycemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Roux en Y Gastric Bypass Surgery, Hypoglycemia, Postprandial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gastric Bypass Surgery population

liquid mixed meal tolerance test, solid mixed meal tolerance test, continuous glucose monitoring

Post Prandial Hypoglycemia test

Intervention Type DIAGNOSTIC_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

Post Prandial Hypoglycemia test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Post Prandial Hypoglycemia test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Endocrinology, UZ Ghent Hospital

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B670201731703

Identifier Type: -

Identifier Source: org_study_id