Status:
COMPLETED
Evaluation of the Neuro-endocrine Response to Post-prandial Hyperinsulinaemic Hypoglycaemia.
Lead Sponsor:
Lia Bally
Conditions:
Roux-en-y Gastric Bypass
Post Prandial Hypoglycemia
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to assess the neuro-endocrine response to hypoglycaemia in PHH vs. non-PHH post-gastric bypass individuals.
Detailed Description
Obesity is a major global public health concern, for which the most effective therapy is bariatric surgery. Beyond weight loss, bariatric surgery exerts powerful effects on glucose metabolism, achievi...
Eligibility Criteria
Inclusion
- Inclusion criteria for PHH patients (Group 1):
- Aged ≥18 years
- Roux-en-Y gastric bypass ≥1 year ago
- PHH defined as postprandial plasma or sensor glucose\<3.0mmol/l according to the International Hypoglycaemia Study Group (1) and exclusion of other causes of hypoglycaemia
- Inclusion criteria for non-PHH surgical controls (Group 2 and 3):
- Aged ≥18 years
- Roux-en-Y gastric bypass (Group 2) or sleeve gastrectomy (Group 3) ≥1 year ago
- No evidence of PHH
- Inclusion criteria for non-PHH non-surgical controls (Group 4):
- Aged ≥18 years
- Absence of any condition or previous surgery known to affect gastro-intestinal integrity and food absorption
- Exclusion criteria for all Groups:
- Clinically relevant weight changes (≥5%) within the past 3 months
- Incapacity to give informant consent
- Historical or current diabetes based on HbA1c ≥6.5% without glucose-lowering treatment
- Haemoglobin level below 13.5 g/l
- Ongoing treatment with glucose-lowering drugs, anorectic drugs, steroids or any medications known to affect gastric motility
- Active heart, lung, liver, gastrointestinal, renal or neurological disease
- Inability to follow study procedures
- Pregnancy or breast-feeding
Exclusion
Key Trial Info
Start Date :
October 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04334161
Start Date
October 2 2020
End Date
July 13 2021
Last Update
August 10 2021
Active Locations (1)
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1
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism
Bern, Switzerland, 3010