Bariatric Surgery Clinical Trial
— HYPOBAR1Official title:
Exploring Beta Cell Function in Individuals With Postbariatric Postprandial
Verified date | December 2018 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Postprandial hyperinsulinaemic hypoglycaemia is an increasingly recognized adverse side effect of bariatric surgery. Affected individuals experience low glucose levels 1-3 hours after intake of meals, accompanied by symptoms such as drowsiness, sweating, hunger and palpitations. Hypoglycaemia can be serious and have potential dangerous health impact (e.g. road accident or fall due to loss of consciousness). The pathophysiology is incompletely understood and more research is needed in search of preventive and therapeutic strategies.
Status | Completed |
Enrollment | 16 |
Est. completion date | November 2, 2018 |
Est. primary completion date | November 2, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Gastric bypass (RYGB) surgery performed = 6 months ago - Confirmed postprandial hypoglycaemia (continuous glucose monitoring or plasma glucose), with at least 2 episodes of Whipple's triad (symptoms, capillary of interstitial glucose =3.1mmol/L, symptom resolution by carbohydrate intake) =3 months ago - Normal glucose control at recruitment and absence of (pre)diabetes before bariatric surgery - Capacity to give informed consent Exclusion Criteria: - Fasting hypoglycaemia suggesting hyperinsulinism of different aetiology - Use of medication that influence glucose metabolism - Bariatric procedures other than RYGB - Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator - Moderate to severe chronic kidney disease - Pregnancy or breastfeeding |
Country | Name | City | State |
---|---|---|---|
Switzerland | Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Erasmus Medical Center |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fractional synthesis rate of de novo C-peptide synthesis (%/hr) | Calculated | 4.5 hours | |
Secondary | C-peptide levels in blood | Measured | 4.5 hours | |
Secondary | Insulin levels in blood | Measured | 4.5 hours | |
Secondary | Glucagon levels in blood | Measured | 4.5 hours | |
Secondary | Incretin levels in blood | Measured | 4.5 hours | |
Secondary | Insulin sensitivity | Calculated | 4.5 hours | |
Secondary | Beta cell responsivity | Calculated | 4.5 hours | |
Secondary | Hepatic insulin extraction | Calculated | 4.5 hours | |
Secondary | C-peptide levels in urine | Measured | 4.5 hours | |
Secondary | C-peptide enrichment | calculated | 4.5 hours |
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