LAMAinDiab - lisdexamphetamine vs methylphenidate for pediatric patients with ADHD and type 1 diabetes - a randomized crossover clinical trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- The difference in ADHD symptom scores on the scale of "inattention" of the Conners 3 questionnaire between the measurement before pharmacotherapy (after completion of PTBM) and the measurement at the end of the 6-month course of pharmacotherapy with LDX or MPH; and a similar difference (between the value measured before pharmacotherapy and after 6 months of therapy) for the other drug (endpoint assessment by the investigator blinded to patient allocation).
研究概览
简要总结
Patients with ADHD and type I diabetes.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 8-16.5 years at study entry
- •T1D diagnosed on the basis of clinical features, presence of autoantibodies typical for type 1 diabetes (at least one of the following: anti-GAD, ICA, IAA/IA2, ZnT8) and/or low C-peptide levels (according to the laboratory standard appropriate for the assay method) and criteria for the diagnosis of diabetes according to the criteria of the Polish Diabetes Association and international societies: - an incident glycemia ≥200mg/dl and symptoms of hyperglycemia (such as increased thirst, polyuria, weakness) or - two times a fasting blood glucose ≥126mg/dl or - A blood glucose ≥200mg/dL in the 120th minute of an oral glucose load test or - HbA1c ≥6.5%.
- •T1D treated with functional intensive insulin therapy
- •T1D lasting at least 12 months at the time of study inclusion
- •a diagnosis of ADHD according to DSM-5 criteria confirmed by a psychiatrist or a diagnosis of ADHD according to other criteria recognized in Poland, confirmed by an authorized person as consistent with DSM-5
- •Polish citizenship and Polish health insurance
- •For patients capable of becoming pregnant who have begun cohabitation, the use of effective contraception for the entire period of participation in the study, and for patients who have not begun cohabitation, the maintenance of sexual abstinence.
排除标准
- •Daily insulin dose<0.3 j/kg and concomitant HbA1c measurement ≤6.5% from the last 3 months (clinical partial remission of T1D);
- •Diagnosed hyperthyroidism requiring treatment.
- •Newly diagnosed diseases that may affect the evaluation of the effectiveness of investigational medicinal products or the safety of the trial participant: hypertension, hypothyroidism, celiac disease, anemia, others at the discretion of the Investigator. It is possible that the child may be included in the clinical trial after appropriate treatment has been instituted and the clinical condition has been stabilized.
- •Lack of permanent residence in the Republic of Poland.
- •Pregnancy or breastfeeding.
- •Declared by parents/legal guardians lack of the ability or willingness to come to the Site at the time specified by the protocol, in particular - to receive the investigational medicinal product at the dosage adjustment stage (need to pick up 4-5 times over 6-8 weeks, each time within 2-3 days of receipt of recommendations).
- •Other reasons that, in the opinion of the investigator, are more likely than not to result in difficulties in maintaining the continuity of the participant's participation in the trial or harm to the participant's health if he or she participates in the trial.
- •Recognized allergy or hypersensitivity to drugs used in drug intervention pharmacological intervention methylphenidate and/or lisdexamphetamine.
- •Language barrier preventing full psychological consultation in Polish.
- •Extremely abnormal diabetes compensation - mean HbA1c before signing informed consent ≥12% (not including HbA1c measurement at diagnosis of T1D)
- •Diagnosis of intellectual disability or other disability, preventing participation in the study or adaptation to its therapeutic regime (in the case of autism, the decision is made by the Investigator)
- •Short stature (height ≤ 3pc according to Center for Child Health centile grids Children's Health OLA and OLAF studies);
- •Underweight (body weight ≤ 3pc according to the center's centile grids Children's Health OLA and OLAF studies).
- •A diagnosed mental illness or disorder that prevents Participation in the trial, e.g., bipolar affective disorder, schizophrenia, other psychotic disorders
- •Diagnosed hemodynamically significant heart defect, advanced vascular atherosclerosis
结局指标
主要结局
The difference in ADHD symptom scores on the scale of "inattention" of the Conners 3 questionnaire between the measurement before pharmacotherapy (after completion of PTBM) and the measurement at the end of the 6-month course of pharmacotherapy with LDX or MPH; and a similar difference (between the value measured before pharmacotherapy and after 6 months of therapy) for the other drug (endpoint assessment by the investigator blinded to patient allocation).
The difference in ADHD symptom scores on the scale of "inattention" of the Conners 3 questionnaire between the measurement before pharmacotherapy (after completion of PTBM) and the measurement at the end of the 6-month course of pharmacotherapy with LDX or MPH; and a similar difference (between the value measured before pharmacotherapy and after 6 months of therapy) for the other drug (endpoint assessment by the investigator blinded to patient allocation).
The difference in ADHD symptom scores on the hyperactivity/impulsivity scale of the Conners 3 questionnaire between the pre-drug (post-PTBM) and post-drug (6-month LDX or MPH) measures; and the corresponding difference (between the pre-drug and 6-month measures) for the second drug (endpoint assessed by an investigator blinded to patient allocation).
The difference in ADHD symptom scores on the hyperactivity/impulsivity scale of the Conners 3 questionnaire between the pre-drug (post-PTBM) and post-drug (6-month LDX or MPH) measures; and the corresponding difference (between the pre-drug and 6-month measures) for the second drug (endpoint assessed by an investigator blinded to patient allocation).
The number and frequency of adverse events described by the MedDRA dictionary reported in both cycles of pharmacotherapy.
The number and frequency of adverse events described by the MedDRA dictionary reported in both cycles of pharmacotherapy.
次要结局
- Difference in HbA1c measured at the end of MPH pharmacotherapy cycle and LDX relative to the measurement before pharmacotherapy was started.
- Difference in percentage of time spent by child for 14 days at the end of the MPH and LDX pharmacotherapy cycle relative to the 14 days preceding the initiation of pharmacotherapy in the following CGM measurement glycemic ranges: - target (70-180mg/dl), - hypoglycemia (<70mg/dl), - clinically significant hypoglycemia (<54mg/dl), - hyperglycemia (>180mg/dl), - significant hyperglycemia (>250mg/dl).
- Difference in the mean glycemia and in the coefficient of variation of the of glycemia calculated as the ratio of the standard deviation of the of glycemia to mean glycemia (expressed as a percentage) calculated for the 14 days at the end of the MPH and LDX pharmacotherapy cycle vs.14 days prior to the start of pharmacotherapy 14 days prior to pharmacotherapy initiation.
- Difference between declared quality of life and quality of life with diabetes of the study participant after each cycle of pharmacotherapy (LDX or MPH) relative to the quality of life assessed at the time point after completion of PTBM, preceding the initiation of pharmacotherapy.
- Difference between the declared quality of life and the quality of life with diabetes of the study participant after each cycle of pharmacotherapy (LDX or MPH) relative to the quality of life assessed at the time point after completion of PTBM, preceding initiation of pharmacotherapy.
研究者
Agnieszka Butwicka
Scientific
Medical University Of Lodz