Phase
Condition
Diabetes (Pediatric)
Hormone Deficiencies
Treatment
Canakinumab
Placebo (0.9% NaCl)
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients after bariatric surgery (i.e. sleeve gastrectomy, Roux-en-Y gastric bypass,omega-loop bypass, biliopancreatic diversion) with documented hypoglycemia, i. e. < 3.0 mmol/l and at least 5 hypoglycemic episodes per week despite dietarymodification
For women with child-bearing potential, willingness to use contraceptive measuresadequate to prevent pregnancy during the study
Informed Consent as documented by signature
Exclusion
Exclusion Criteria:
Any type of diabetes mellitus according to ADA criteria
Intolerance to the study drug
Signs of current infection
Any use of immunosuppressive medication
Use of any drug therapy for postbariatric hypoglycemia apart from acarbose (allremaining drugs have to be discontinued four half-life times before screening phase)
Neutropenia (leukocyte count < 1.5 × 109/L or 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, AST/ALT > 2 × ULN, alkaline phosphatase > 2 × ULN, or total bilirubin [tBili] > 1.5 × ULN)
Uncontrolled congestive heart failure
Uncontrolled malignant disease
Currently pregnant or breastfeeding
Known or suspected non-compliance, drug or alcohol abuse
Meeting the criteria for vulnerability (e.g. participants incapable of judgment orparticipants under tutelage)
Inability to follow the procedures of the study, e.g. due to language problems,psychological disorders, dementia, etc.
Participation in another clinical trial using investigational drugs in the last 30days or planned participation in the next 60 days
Previous enrolment into the current study,
Enrolment of the investigator, his/her family members, employees and other dependentpersons
Study Design
Study Description
Connect with a study center
University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism
Basel, 4031
SwitzerlandActive - Recruiting
Cantonal Hospital Olten, Division of Endocrinology
Olten, 4600
SwitzerlandActive - Recruiting
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