Canakinumab treatment for low blood sugar after weight loss surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Canakinumab use in Schnitzler’s syndrome in real-world patients

  This study tests how well and how safely canakinumab works for people diagnosed with Schnitzler’s syndrome who are taking it in routine clinical care.

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• Canakinumab use in FMF and Still's disease patients across real-world care

  This real-world study looks at how people with FMF or Still's disease who were treated with canakinumab fare over at least 6 months.

  Recruiting Novartis · Basel · NCT07517250

• Using canakinumab to prevent cancer in patients with low blood cell counts

  This study is testing if the drug canakinumab can help prevent cancer in people with low blood cell counts and certain genetic changes.

  Recruiting at 6 sites Phase 2 Ohio State University Comprehensive Cancer Center · Miami, Florida and 5 other locations · NCT05641831

• Using canakinumab to prevent lung cancer in high-risk patients

  This study is testing if a medication called canakinumab can help prevent lung cancer in people who have high-risk lung nodules.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT04789681

• Treatment of low or intermediate-risk myelodysplastic syndromes and chronic myelomonocytic leukemia with canakinumab

  This study is testing if a new medication called canakinumab can help people with low or intermediate-risk myelodysplastic syndromes and chronic myelomonocytic leukemia feel better and reduce their need for blood transfusions.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT04239157

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.