Postprandial Hypoglycemia in Patients After Bariatric Surgery With Empagliflozin and Anakinra - The Hypo-BEAR-Study

• Status: Completed
• Trial end date: 2018-09-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate whether hypoglycaemia observed after food intake in bariatric patients can be either influenced by an SGLT2 inhibitor, empagliflozin, or via inhibition of inflammation with an human interleukin-1 receptor antagonist (IL1-RA, anakinra).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Empagliflozin; Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Patients after roux-y-gastric bypass or biliopancreatic diversion with documented hypoglycemia, i. e. ≤ 2.5 mmol/l and hypoglycaemic symptoms.

• For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study

Exclusion Criteria:

• Signs of current infection

• Use of any investigational drug in the last four weeks prior to enrolment

• Use of any anti-diabetic drugs

• adrenal insufficiency and/or substitution with glucocorticoids

• Neutropenia (leukocyte count < 1.5 × 109/L or absolute neutrophil count (ANC) < 0.5 × 109/L)

• Anemia (hemoglobin < 11 g/dL for males, < 10 g/dL for females)

• Clinically significant kidney or liver disease (creatinine > 1.5 mg/dL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 × ULN, alkaline phosphatase > 2 × ULN, or total bilirubin [tBili] > 1.5 × ULN)

• Current immunosuppressive treatment or documented immunodeficiency

• Uncontrolled congestive heart failure

• Uncontrolled malignant disease

• Currently pregnant or breastfeeding

• known lactose intolerance