2025-524318-27-00招募中2 期
VIP-1 : Preclinical type 1 diabetes: the VIP-1 Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Beta-cell function - measured by disposition index during OGTT - after 48 weeks of treatment.
研究概览
简要总结
To test the effect of 48 - week treatment with verapamil in people with Stage 1 or Stage 2 T1D on beta cell function, quantified through mathematical metabolic modelling (OMM) during an oral glucose tolerance test (OGTT).
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •age 7 to 45 years
- •Stage 1 T1D (presence of at least two islet autoantibodies without dyslgycemia) or Stage 2 T1D (presence of at least one islet autoantibody with 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 (estrogen-progestin or progestin-only contraception, or an intrauterine device, or contraceptive abstinence)
- •Inclusion of a single family member
排除标准
- •Blood pressure (either systolic or diastolic) <5th centile for age, sex, (or systolic <100 mmHg in adults) on two out of three measurements.
- •Use of beta blockers, seizure medications (carbamazepine, phenobarbital, phenytoin), antihypertensive medications, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine, or aspirin.
- •Known hypersensitivity to verapamil.
- •Contraindications to verapamil
- •Adult patients (or legal guardians) whose limited proficiency in French prevents them from receiving fully informed information about the protocol
- •People with Stage 2 T1D who previously received a cycle of treatment with teplizumab (anti-CD3)
- •Pregnant or breastfeeding women.
- •Patient under guardianship, conservatorship or legally detained
- •Patient participating in another clinical trial investigating a disease modifying treatment (e.g. immunotherapy or others)
- •Pulse <2nd percentile for age and sex (or<50/min in adults) on two out of three measurements;
- •History of vasovagal syncopal episodes related to hypotension over the past 12 months,
- •Abnormal EKG rhythm, unless cleared for study participation by a cardiologist, known cardiac disease,
- •Arrhythmias unless cleared for study participation by a cardiologist,
- •Known renal impairment (eGFR<90ml/min/1.73m2), Duchenne’s muscular dystrophy, active Graves’ disease or hyperthyroidism and untreated hypothyroidism, AST and/or ALT >3-fold the upper limit of normal.
结局指标
主要结局
Beta-cell function - measured by disposition index during OGTT - after 48 weeks of treatment.
Beta-cell function - measured by disposition index during OGTT - after 48 weeks of treatment.
次要结局
- Proinsulin-to-C-peptide ratio during OGTT at baseline, 24 and 48 weeks
- Chromogranin A/GLP-1/GIP during OGTT at baseline, 24 and 48 weeks
- Changes in disposition index components: insulin sensitivity and insulin secretion measured by metabolic modelling during 24-week and 48 weeks OGTT.
- CD4+/CD8+ T-cell responses of peripheral blood monocytes to type 1 diabetes-associated antigens at baseline and 48 weeks
- Percentage change in time spent in glucose ranges (70-140 mg/dL, 70-180 mg/dL) and glucose variability (SD, CV, CONGA1, 2 and 4) during sensor sessions (CGM) at 10 days, 24 and 48 weeks after treatment initiation
研究者
Dr Alfonso Galderisi
Scientific
Assistance Publique Hopitaux De Paris
研究点 (7)
Loading locations...
相似试验
招募中
3 期
一项在近期确诊 3 期 1 型糖尿病（T1D）的 1 至 25 岁参与者中评估 teplizumab 与安慰剂相比的有效性和安全性的随机、双盲、Ⅲ 期研究1 型糖尿病ChiCTR2600122711赛诺菲（中国）投资有限公司723
尚未招募
早期 1 期
Autologous CD6-CAR Treg Cells for Patients With Stage 3 Type 1 DiabetesNCT07395050City of Hope Medical Center6
进行中（未招募）
3 期
一项在 1 至 25 岁 3 期 1 型糖尿病参与者中评估 teplizumab 与安慰剂相比的有效性和安全性的研究1 型糖尿病CTR20253851Sanofi-Aventis Recherche & Développement/
赛诺菲（中国）投资有限公司/
Ajinomoto Althea, Inc.
招募中
3 期
一项在 1 至 25 岁 3 期 1 型糖尿病参与者中评估 teplizumab 与安慰剂相比的有效性和安全性的研究1 型糖尿病CTR20253851Sanofi-Aventis Recherche & Développement/
赛诺菲（中国）投资有限公司/
Ajinomoto Althea, Inc.
尚未招募
Phase 3 4
Adjuvant Effect Of Nisha-Amlaki And Mahadadimadi Ghrita With Insulin In Diabetes Type I In Pediatric PopulationCTRI/2024/04/066012All India Institute of Ayurveda, New Delhi72