Status:
COMPLETED
Assessing Insulin Turnover Using an In-vivo Deuterated Water Experiment.
Lead Sponsor:
Lia Bally
Conditions:
Bariatric Surgery
Hypoglycemia
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to observe the kinetics of pre-stored and de-novo synthesized insulin that is secreted into the circulation using an in-vivo heavy water (D2O) labelling experime...
Detailed Description
Despite an increased prevalence, the underlying pathophysiology of PHH remains incompletely understood. It is generally assumed that PHH is caused by excess insulin secretion, either due to an intrins...
Eligibility Criteria
Inclusion
- Inclusion criteria for PHH patients:
- 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 and exclusion of other causes of hypoglycaemia
- Inclusion criteria for non-PHH non-surgical controls:
- Aged ≥18 years
- Absence of any condition or previous surgery known to affect gastro-intestinal integrity and food absorption
- Exclusion Criteria:
- 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 :
July 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 20 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04332289
Start Date
July 9 2020
End Date
August 20 2020
Last Update
October 1 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital
Bern, Switzerland, 3010