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.
Arkadiusz Mariusz MichalakJędrzej ChrzanowskiHanna Kuśmierczyk-KoziełEwa KlejmanKatarzyna BłaziakBeata MianowskaAgnieszka SzadkowskaAgata P ChobotPrzemysława Jarosz-ChobotMałgorzata MyśliwiecIwona MakowskaAnna KalenikMonika ZamarlikTomasz WolańczykWojciech FendlerAgnieszka ButwickaPublished in: BMJ open (2023)
EU Clinical Trials Register (EU-CTR, 2022-001906-24) and NCT05957055.
Keyphrases
- clinical trial
- type diabetes
- double blind
- study protocol
- open label
- phase ii
- end stage renal disease
- newly diagnosed
- ejection fraction
- randomized controlled trial
- attention deficit hyperactivity disorder
- emergency department
- prognostic factors
- cardiovascular disease
- insulin resistance
- patient reported outcomes
- adipose tissue
- metabolic syndrome
- glycemic control
- skeletal muscle
- placebo controlled
- weight loss