Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-198
SponsorMedical University of Lodz
About this trial
This clinical trial aims to evaluate the safety and effectiveness of an intervention involving parental training in behaviour management and medication in children with both Type 1 Diabetes (T1D) and Attention Deficit Disorder with Hyperactivity (ADHD). ADHD is a neurodevelopmental disorder that affects around 5% of school-age children and adolescents, while T1D is a chronic disease requiring strict management.
After initial parental training provided for parents/legal guardians, the children will be randomized to one of two cross-over groups, and treated with either lisdexamfetamine or methylphenidate first. After dose optimization for first 5-7 weeks, patients will be treated for 6 months total, after which they will be switched to the other drug.
Researchers will then compare the ADHD symptom severity as measured by Conners 3 questionnaire, and compare the frequency of any adverse events associated with the therapy. As secondary outcomes, patient's T1D control and quality of life will be compared between the two drugs.
Eligibility criteria
Qualifiers
Age 8-16.5 years at study entry;
an incidental glycemia ≥200mg/dl and symptoms of hyperglycemia (such as increased thirst, polyuria, weakness) or
two times a fasting blood glucose ≥125mg/dl or
a blood glucose ≥200mg/dL in the 120th minute of an oral glucose load test or
Disqualifiers
Daily insulin dose<0.3 j/kg and concomitant HbA1c measurement ≤6.5% from the last 3 months (clinical partial remission of T1D);
Severely unsatisfactory glycemic control - mean HbA1c over the past year ≥12% (not including HbA1c measurement at diagnosis of T1D);
Diagnosed intellectual or other disability that prevents participation in the trial or adherence to its therapeutic regimen;
Clinically apparent cardiovascular disease: recognized hemodynamically significant heart defect, advanced vascular atherosclerosis;
Trial design
Treatments tested in this trial
- parental training in behavior management
- Lisdexamfetamine
- Methylphenidate
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Medical University of Lodz
Lead sponsor
Medical University of Silesia
Collaborator
Medical University of Gdansk
Collaborator
Institute of Medical Sciences of the University of Opole
Collaborator
Pediatric Center of the Central Clinical Hospital of the Medical University of Lodz
Collaborator
Source ClinicalTrials.gov