Canakinumab treatment for low blood sugar after weight loss surgery
Canakinumab for the Treatment of Postprandial Hypoglycemia - CanpHy Study
This study is testing if a medication called canakinumab can help people who have had weight loss surgery manage low blood sugar after meals.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | canakinumab |
| Locations | 2 sites (Basel and 1 other locations) |
| Trial ID | NCT05401578 on ClinicalTrials.gov |
What this trial studies
This randomized clinical trial aims to evaluate the effectiveness of canakinumab, an IL-1 receptor antagonist, in treating postprandial hypoglycemia in patients who have undergone bariatric surgery. Participants will be monitored using a continuous glucose monitoring system to assess their hypoglycemic episodes over a 28-day treatment period compared to a placebo group. The study will also measure improvements in health-related quality of life, both mentally and physically, as a primary outcome. The total duration of participation for each subject is expected to be four months, including screening and follow-up visits.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone bariatric surgery and experience frequent hypoglycemic episodes despite dietary modifications.
Not a fit: Patients with any type of diabetes mellitus or those currently on immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from postprandial hypoglycemia after bariatric surgery.
How similar studies have performed: Previous studies have shown that IL-1 receptor antagonists like Anakinra can reduce symptomatic hypoglycemia, suggesting potential success for this similar approach with canakinumab.
Eligibility criteria
Show full inclusion / exclusion criteria
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 dietary modification * For women with child-bearing potential, willingness to use contraceptive measures adequate to prevent pregnancy during the study * Informed Consent as documented by signature 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 (all remaining 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 or participants 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 30 days 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 dependent persons
Where this trial is running
Basel and 1 other locations
- University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism — Basel, Switzerland (Recruiting)
- Cantonal Hospital Olten, Division of Endocrinology — Olten, Switzerland (Recruiting)
Study contacts
- Principal investigator: Marc Y Donath, Prof. Dr. — University of Basel
- Study coordinator: Marc Y Donath, Prof. Dr.
- Email: marc.donath@usb.ch
- Phone: +41 61 265 25 25
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.