NCT07880769Toborzás még nem indult2/3. fázis
Verapamil In Preclinical Type 1 Diabetes
Preclinical Type 1 Diabetes: the VIP-1 Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 22.
Rövid összefoglaló (regiszter, angolul)
Type 1 diabetes (T1D) is preceded by a presymptomatic phase featured by the presence of islet autoantibodies (aAbs) without (Stage 1) or with (Stage 2) dysglycemia. Clinical investigations targeting Stage 1 or Stage 2 disease have been using the time to clinical disease progression (Stage 3) as primary outcome, with a consequent need for relative high numerosity and prolonged follow-up. Additional hurdles limit the feasibility of disease modifying therapy (DMT) trials for preclinical T1D, including the need for an established screening program able to identify those who might be eligible and the enrolment of relatively large cohorts followed until clinical onset. To overcome these major limitations, our group recently explored the use of mathematical metabolic modelling of beta cell function in the early disease stages of T1D and its ability to quantify the response to treatment. We gathered, for the current proposal, sites with an established screening program for family members of people with T1D. The evidence obtained in our previous experience led to the design of this trial aimed to test the effect of a calcium channel blocker - verapamil - on beta cell function, as quantified through mathematical modelling, in Stage 1 disease. While this drug was previously tested in children and adolescents in the early clinical phases of the disease (Stage 3), it has never been used in Stage 1 disease. Verapamil inhibits beta cell apoptosis in animal models and has been shown to increase C-peptide secretion in adults with recent onset T1D and in youths. We hypothesize that an earlier treatment with verapamil targeting people with Stage 1 disease, whose residual beta cell function is greater than those with Stage 3 disease, may result in prolonged preservation of beta cell functional mass - and, consequently, in delayed clinical progression.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2/3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 50 (tervezett)
- Első benyújtás
- 2026. okt. 12.
- Kezdés
- 2027. jan.
- Elsődleges befejezés
- 2031. márc.
- Fő szponzor
- Assistance Publique - Hôpitaux de Paris
- Betegségek
- 1-es típusú cukorbetegség
- NCT-szám
- NCT07880769
- EU CT-szám
- 2025-524318-27-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
- Tervezett résztvevők: 50
- 2027. jan. és az elsődleges befejezés (2031. márc.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- People with who previously received a cycle of treatment with teplizumab (anti-CD3)
- Adult patients (or legal guardians) whose limited proficiency in French prevents them from receiving fully informed information about the protocol
Más betegség
- History of vasovagal syncopal episodes related to hypotension over the past 12 months,
- Abnormal EKG rhythm or arrhythmias known cardiac disease,
- Arrhythmias unless cleared for study participation by a cardiologist,
- Use of beta blockers, seizure medications (carbamazepine, phenobarbital, phenytoin), antihypertensive medications, reductase inhibitors, lithium, theophylline, clonidine, or aspirin;
- Known hypersensitivity to verapamil.
- Patient participating in another interventional clinical trial investigating a disease modifying treatment (e.g. immunotherapy or others)
Laborértékek
- Known renal impairment, Duchenne's muscular dystrophy, active Graves' disease or hyperthyroidism and untreated hypothyroidism, AST and/or ALT >3-fold the upper limit of normal;
Életkor
- Blood pressure (either systolic or diastolic) <5th centile for age, sex, (or systolic <100 mmHg in adults) on two out of three measurements.
- Pulse <2nd percentile for age and sex (or<50/min in adults) on two out of three measurements;
Egyéb
- Contraindications to verapamil
- Pregnant women or breastfeeding mothers will not be eligible for the study
- Patient under guardianship, conservatorship or legally detained
Kiket keres a vizsgálat
- age 7 to 45 years;
- Stage 1 T1D (presence of at least two islet autoantibodies without dysglycemia)
- body weight ≥30 kg;
- Obtaining written informed consent signed by the adult subject or by legal guardians in the case of a minor; and the approval of the minor patient
- Patient affiliated to a social security scheme (beneficiary or beneficiary's beneficiary);
- Patients of childbearing age who are sexually active must agree to use a highly effective form of contraception.
- Inclusion of a single family member
Életkor a regiszterben: 7 év – 45 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hopital Robert Debre | Paris | Franciaország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.