IL-1-receptor Antagonist During Cephalic Phase of Insulin Secretion in Health and Type 2 Diabetes (NCT04227769) | Clinical Trial Compass
TerminatedPhase 2
IL-1-receptor Antagonist During Cephalic Phase of Insulin Secretion in Health and Type 2 Diabetes
Stopped: Too low recruitment in group with patients with diabetes.
Switzerland18 participantsStarted 2020-01-13
Plain-language summary
A prospective, randomized, mixed double- and single-blinded, placebo-controlled, cross-over clinical trial to test whether acute treatment with an IL-1 receptor antagonist impacts insulin secretion over time during the cephalic phase, defined as the first 10 minutes after the first sensorial contact to food, in healthy individuals in healthy humans (Group 1) and in obese patients with type 2 diabetes (Group 2).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
Main inclusion criteria:
* Age ≥ 18 years and ≤ 70 years at screening
* Male or female of non-child-bearing potential (meaning for women: not currently pregnant, post-menopausal female or using condoms and either intrauterine devices or 3-monthly contraceptive injection or birth-control pill.)
Healthy subjects:
* No apparent disease requiring medication
* BMI \< 25 kg/ m2
* C-reactive protein ≤ 2 mg/L
Obese diabetic type 2 subjects:
* Type 2 diabetes
* HbA1c 7.0 -10.0%
* BMI ≥ 30.0 kg/m2
* C-reactive protein ≥ 2 mg/L
Exclusion criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Aversion or allergy to paracetamol or any component of the meal.
* Known history of allergy or hypersensitivity to any component of the investigational product formulations
* Concomitant treatment with GLP-1 agonists, DPP-4 inhibitors, insulin or insulin derivative
* Change in diabetes medication within the last 30 days
* Any biologic drugs targeting the immune system
* Fever, or other signs of infection requiring antibiotics within 3 weeks prior to screening, history of recurrent infection, immunodeficiency, known HIV or tuberculosis infection, active foot ulcer
* Participation in another study with investigational drug within 30 days prior to Screening and during the present study
* eGFR \< 30 mL/min/1.73m2 per MDRD formula …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in insulin concentration in blood during the cephalic phase of insulin secretion in healthy individuals
Timeframe: 10 minutes
2
Change in insulin concentration in blood during the cephalic phase of insulin secretion in obese patients with type 2 diabetes