Status:
COMPLETED
Validation of a Diagnostic Tool for Postprandial Hypoglycaemia in Patients After Roux en Y Gastric Bypass Surgery
Lead Sponsor:
University Ghent
Conditions:
Post Prandial Hypoglycemia
Eligibility:
All Genders
18-70 years
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 v...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 5 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03406312
Start Date
June 1 2017
End Date
May 5 2020
Last Update
December 1 2021
Active Locations (1)
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1
Endocrinology, UZ Ghent Hospital
Ghent, Belgium, 9000