NCT06770621招募中不适用
Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes (GLUREDIA Study): Characteristics and Predictive Biomarkers.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年5月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- To investigate the evolution of pancreatic α-cell function. (WP1)
研究概览
简要总结
The GLUREDIA study investigates the counter-regulatory response (CRR) during hypoglycemia in children with type 1 diabetes (T1D). Hypoglycemia can lead to severe symptoms, but is normally counteracted by CRR, corresponding to the secretion of hormones to maintain normoglycemia. Hypoglycemia is common in T1DM but some patients develop severe hypoglycemia as a result of CRR dysfunction. Despite several studies in adults, the presence of CRR dysfunction remains unpredictable and not well understood. The objective of GLUREDIA is therefore to describe and predict the evolution of CRR in children with T1DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •De novo type 1 diabetic patient, as per ISPAD criteria;
- •Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +/- Acido ketosis.
- •Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at 120 minutes of an OGTT AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see
- •a. 2.) with random blood glucose ≥200 mg/dL.
- •Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
- •Patients aged between 2 and 30 years
- •Minimum weight: 17 kg (for blood samples)
- •Male - female patients
- •Free, written and oral consent.
排除标准
- •Child under 2 years of age.
- •Taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
- •Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
- •Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
- •Obesity defined as a BMI with a z-score >+3 SD.
- •Hepatic, renal or adrenal insufficiency.
- •History of bone marrow transplantation.
- •History of diabetes after hemolytic-uremic syndrome.
- •Epileptic patient
- •Absence of anti-islet autoantibodies.
- •Dysmorphia with suspicion of underlying genetic syndrome.
- •Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.
- •Inclusion Criteria:
- •De novo type 1 diabetic patient, as per ISPAD criteria;
- •Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +/- Acido ketosis.
- •Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at 120 minutes of an OGTT AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see
- •a. 2.) with random blood glucose ≥200 mg/dL.
- •Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
- •Patients aged between 2 years and 18 years (<18 years).
- •Male - female patients
- •Free, written and oral consent.
- •Exclusion criteria:
- •Child under 2 years of age.
- •Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
- •Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
- •Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
- •Obesity defined as a BMI with a z-score >+3 SD.
- •Hepatic, renal or adrenal insufficiency.
- •History of bone marrow transplantation.
- •History of diabetes after hemolytic-uremic syndrome.
- •Absence of anti-islet autoantibodies.
- •Dysmorphia with suspected underlying genetic syndrome.
- •Participation in another study within the previous 3 months with administration of blood derivatives or potentially immunomodulatory treatments.
- •Inclusion Criteria:
- •Adult older than 18 years.
- •Absence of blood marker of diabetes (Absence of antibodies, HbA1C <6.5%, C-peptide > 0.18 nmol/L, Fasting blood glucose < 100 mg/dL, blood glucose at any time < 200 mg/dL).
- •Be a first-degree relative with a patient being followed for diabetes (meeting ISPAD criteria).
- •Male - Female
- •Free written and oral consent
- •Exclusion criteria:
- •Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
- •Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
- •Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
- •Obesity defined as a BMI with a z-score >+3 SD.
- •Hepatic, renal or adrenal insufficiency.
- •History of bone marrow transplantation.
- •History of diabetes after hemolytic-uremic syndrome.
- •Ischemic cardiomyopathy
- •Pregnant participant
- •Epileptic patient
- 另有 83 项未显示
结局指标
主要结局
To investigate the evolution of pancreatic α-cell function. (WP1)
时间窗: 18 months per patient
Regular clinical and biological monitoring will be performed during this period as well as four insulin-induced hypoglycemia (IIH) tests.
To evaluate the presence of blood biomarkers that correlate with the evolution of α-cell function. (WP1)
时间窗: 18 months per patient
Regular clinical and biological monitoring will be performed during this period as well as four insulin-induced hypoglycemia (IIH) tests. Hormones and other blood parameters will be measured and genome, proteome and microRNA (miRs) analysis will be performed during the IIH tests and during the biological follow-up. The expected results are the description and prediction of CRR in the first months after T1DM.
次要结局
- Conduct an assessment of the management of severe hypoglycemia. (WP2)(Baseline)
- Evaluate the α-cell function in first-degree relatives of patients with type 1 diabetes. (WP3)(Baseline)
- Characterize the glycemic profile and α-cell function. (WP4)(Baseline)
- Evaluate the phenomenon of counter-regulation in patients with proven growth hormone. (WP5)(Baseline)
- Study the link between the clinical characteristics of diabetic patients and their genome (WP6)(Baseline)
- Evaluation of the circadian rhythm of glucagon (WP7)(Baseline)
研究者
研究点 (2)
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