Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting
Introduction Attention deficit hyperactivity disorder (ADHD) affects 5%–10% of paediatric population and is reportedly more common in children with type 1 diabetes (T1D), exacerbating its clinical course. Proper treatment of ADHD in such patients may thus provide neurological and metabolic benefits....
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
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| author | Przemysława Jarosz-Chobot Agnieszka Szadkowska Małgorzata Myśliwiec Wojciech Fendler Agnieszka Butwicka Arkadiusz Michalak Jędrzej Chrzanowski Hanna Kuśmierczyk-Kozieł Ewa Klejman Katarzyna Błaziak Beata Mianowska Agata P Chobot Iwona Makowska Anna Kalenik Monika Zamarlik Tomasz Wolańczyk |
| author_facet | Przemysława Jarosz-Chobot Agnieszka Szadkowska Małgorzata Myśliwiec Wojciech Fendler Agnieszka Butwicka Arkadiusz Michalak Jędrzej Chrzanowski Hanna Kuśmierczyk-Kozieł Ewa Klejman Katarzyna Błaziak Beata Mianowska Agata P Chobot Iwona Makowska Anna Kalenik Monika Zamarlik Tomasz Wolańczyk |
| author_sort | Przemysława Jarosz-Chobot |
| collection | DOAJ |
| description | Introduction Attention deficit hyperactivity disorder (ADHD) affects 5%–10% of paediatric population and is reportedly more common in children with type 1 diabetes (T1D), exacerbating its clinical course. Proper treatment of ADHD in such patients may thus provide neurological and metabolic benefits. To test this, we designed a non-commercial second phase clinical trial comparing the impact of different pharmacological interventions for ADHD in children with T1D.Methods and analysis This is a multicentre, randomised, open-label, cross-over clinical trial in children and adolescents with ADHD and T1D. The trial will be conducted in four reference paediatric diabetes centres in Poland. Over 36 months, eligible patients with both T1D and ADHD (aged 8–16.5 years, T1D duration >1 year) will be offered participation. Patients’ guardians will undergo online once-weekly training sessions behaviour management for 10 weeks. Afterward, children will be randomised to methylphenidate (long-release capsule, doses 18-36-54 mg) versus lisdexamphetamine (LDX, 30-50-70 mg). Pharmacotherapy will continue for 6 months before switching to alternative medication. Throughout the trial, the participants will be evaluated every 3 months by their diabetologist and online psychological assessments. The primary endpoint (ADHD symptom severity, Conners 3.0 questionnaire) will be assessed by a blinded investigator. Secondary endpoints will include HbA1c, continuous glucose monitoring indices and quality-of-life (PedsQL).Ethics and dissemination The trial is approved by Bioethical Committee at Medical University of Lodz and Polish regulatory agency (RNN/142/22/KE, UR/DBL/D/263/2022). The results will be communicated to the research and clinical community, and Polish agencies responsible for healthcare policy. Patient organisations focused on paediatric T1D will be notified by a consortium member. We hope to use the trial’s results to promote collaboration between mental health professionals and diabetes teams, evaluate the economic feasibility of using LDX in patients with both diseases and the long run improve ADHD treatment in children with T1D.Trial registration numbers EU Clinical Trials Register (EU-CTR, 2022-001906-24) and NCT05957055. |
| format | Article |
| id | doaj-art-be697b9494ee4e50865b97ed45b41f20 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-be697b9494ee4e50865b97ed45b41f202025-08-20T02:11:24ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-078112Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported settingPrzemysława Jarosz-Chobot0Agnieszka Szadkowska1Małgorzata Myśliwiec2Wojciech Fendler3Agnieszka Butwicka4Arkadiusz Michalak5Jędrzej Chrzanowski6Hanna Kuśmierczyk-Kozieł7Ewa Klejman8Katarzyna Błaziak9Beata Mianowska10Agata P Chobot11Iwona Makowska12Anna Kalenik13Monika Zamarlik14Tomasz Wolańczyk15Department of Children`s Diabetology, Medical University of Silesia, Katowice, PolandDepartment of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, Lodz, PolandDepartment of Pediatrics, Diabetology and Endocrinology, Medical University of Gdansk, Gdansk, PolandDepartment of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, PolandInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, NorwayDepartment of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, PolandDepartment of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, PolandDepartment of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, Lodz, PolandDepartment of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, PolandClinical Trials` Unit, Medical University of Lodz, Lodz, PolandDepartment of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, Lodz, PolandDepartment of Pediatrics, University Clinical Hospital in Opole, Opole, PolandChild and Adolescent Psychiatric Department, Medical University of Lodz, Lodz, PolandDepartment of Child Psychiatry, Medical University of Warsaw, Warszawa, PolandFaculty of Health Sciences, Institute of Public Health, Jagiellonian University, Krakow, PolandDepartment of Child Psychiatry, Medical University of Warsaw, Warszawa, PolandIntroduction Attention deficit hyperactivity disorder (ADHD) affects 5%–10% of paediatric population and is reportedly more common in children with type 1 diabetes (T1D), exacerbating its clinical course. Proper treatment of ADHD in such patients may thus provide neurological and metabolic benefits. To test this, we designed a non-commercial second phase clinical trial comparing the impact of different pharmacological interventions for ADHD in children with T1D.Methods and analysis This is a multicentre, randomised, open-label, cross-over clinical trial in children and adolescents with ADHD and T1D. The trial will be conducted in four reference paediatric diabetes centres in Poland. Over 36 months, eligible patients with both T1D and ADHD (aged 8–16.5 years, T1D duration >1 year) will be offered participation. Patients’ guardians will undergo online once-weekly training sessions behaviour management for 10 weeks. Afterward, children will be randomised to methylphenidate (long-release capsule, doses 18-36-54 mg) versus lisdexamphetamine (LDX, 30-50-70 mg). Pharmacotherapy will continue for 6 months before switching to alternative medication. Throughout the trial, the participants will be evaluated every 3 months by their diabetologist and online psychological assessments. The primary endpoint (ADHD symptom severity, Conners 3.0 questionnaire) will be assessed by a blinded investigator. Secondary endpoints will include HbA1c, continuous glucose monitoring indices and quality-of-life (PedsQL).Ethics and dissemination The trial is approved by Bioethical Committee at Medical University of Lodz and Polish regulatory agency (RNN/142/22/KE, UR/DBL/D/263/2022). The results will be communicated to the research and clinical community, and Polish agencies responsible for healthcare policy. Patient organisations focused on paediatric T1D will be notified by a consortium member. We hope to use the trial’s results to promote collaboration between mental health professionals and diabetes teams, evaluate the economic feasibility of using LDX in patients with both diseases and the long run improve ADHD treatment in children with T1D.Trial registration numbers EU Clinical Trials Register (EU-CTR, 2022-001906-24) and NCT05957055.https://bmjopen.bmj.com/content/13/12/e078112.full |
| spellingShingle | Przemysława Jarosz-Chobot Agnieszka Szadkowska Małgorzata Myśliwiec Wojciech Fendler Agnieszka Butwicka Arkadiusz Michalak Jędrzej Chrzanowski Hanna Kuśmierczyk-Kozieł Ewa Klejman Katarzyna Błaziak Beata Mianowska Agata P Chobot Iwona Makowska Anna Kalenik Monika Zamarlik Tomasz Wolańczyk Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting BMJ Open |
| title | Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting |
| title_full | Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting |
| title_fullStr | Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting |
| title_full_unstemmed | Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting |
| title_short | Lisdexamphetamine versus methylphenidate for paediatric patients with attention-deficit hyperactivity disorder and type 1 diabetes (LAMAinDiab): protocol for a multicentre, randomised cross-over clinical trial in an outpatient telemedicine-supported setting |
| title_sort | lisdexamphetamine versus methylphenidate for paediatric patients with attention deficit hyperactivity disorder and type 1 diabetes lamaindiab protocol for a multicentre randomised cross over clinical trial in an outpatient telemedicine supported setting |
| url | https://bmjopen.bmj.com/content/13/12/e078112.full |
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