Actively Recruiting
Canakinumab for the Treatment of Postprandial Hypoglycemia
Led by University Hospital, Basel, Switzerland · Updated on 2025-01-29
56
Participants Needed
2
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this randomized trial is to test whether a treatment with canakinumab is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.
CONDITIONS
Official Title
Canakinumab for the Treatment of Postprandial Hypoglycemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients after bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass, omega-loop bypass, biliopancreatic diversion) with documented hypoglycemia below 3.0 mmol/l and at least 5 episodes per week despite dietary modification
- Women with child-bearing potential must agree to use effective contraception during the study
- Signed informed consent
You will not qualify if you...
- Any type of diabetes mellitus according to ADA criteria
- Intolerance to the study drug
- Signs of current infection
- Use of immunosuppressive medication
- Use of drugs for postbariatric hypoglycemia other than acarbose (other drugs must be stopped 4 half-lives before screening)
- Neutropenia (white blood cell count below specified thresholds)
- Anemia (hemoglobin below 11 g/dL for males, below 10 g/dL for females)
- Significant kidney or liver disease
- Uncontrolled congestive heart failure
- Uncontrolled malignant disease
- Currently pregnant or breastfeeding
- Known or suspected non-compliance, drug or alcohol abuse
- Vulnerability such as inability to give judgment or under tutelage
- Inability to follow study procedures due to language, psychological or cognitive issues
- Participation in another investigational drug trial within 30 days or planned in next 60 days
- Previous enrollment in this study
- Enrollment of investigator or related persons
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism
Basel, Switzerland, 4031
Actively Recruiting
2
Cantonal Hospital Olten, Division of Endocrinology
Olten, Switzerland, 4600
Actively Recruiting
Research Team
M
Marc Y Donath, Prof. Dr.
CONTACT
S
Susanne Ruesch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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