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

NCT03406312 | Completed

• 1 other identifier: B670201731703
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Prandial Hypoglycemia

Keywords

Roux en Y Gastric Bypass Surgery, Hypoglycemia, Postprandial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Association between Ediinburgh Hypoglycemia scale and the lowest postprandial glucose levels

  end 2018

• flow chart for diagnosis of postprandial reactive hypoglyceamia

  end 2018

Study Arms (2)

Gastric Bypass Surgery population

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

Diagnostic Test: Post Prandial Hypoglycemia test

Control population

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

Diagnostic Test: Post Prandial Hypoglycemia test

Interventions

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

Control population; Gastric Bypass Surgery population

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Endocrinology, UZ Ghent Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: June 1, 2017
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

BE (1)