Study on Lisdexamfetamine and Methylphenidate for Children with ADHD and Type 1 Diabetes

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What is this study about?

This clinical trial is focused on studying two conditions: Attention-Deficit Hyperactivity Disorder (ADHD) and Type 1 Diabetes in children and teenagers. The study will compare two medications, Lisdexamfetamine and Methylphenidate, which are used to treat ADHD. Lisdexamfetamine is available in capsule form under the brand name Elvanse, and Methylphenidate is available in tablet form under the brand name Concerta. The purpose of the study is to understand how these medications affect ADHD symptoms and diabetes management in young patients.

Participants in the study will receive both medications at different times, allowing researchers to compare their effects. The study will last for a total of six months, during which participants will take one medication for a period and then switch to the other. Throughout the study, participants will be monitored for changes in ADHD symptoms, as well as any effects on their diabetes, such as blood sugar levels. The study will also track any side effects that may occur while taking these medications.

The goal is to determine which medication is more effective in managing ADHD symptoms while also considering the impact on diabetes control. This information will help doctors make better treatment decisions for children and teenagers who have both ADHD and Type 1 Diabetes. Participants will be closely observed by healthcare professionals to ensure their safety and well-being throughout the study.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of type 1 diabetes and ADHD, and other criteria.

2 randomization

Participants are randomly assigned to start with either lisdexamfetamine dimesylate or methylphenidate hydrochloride for the first treatment cycle.

3 first treatment cycle

The first treatment cycle lasts for 6 months. Participants take the assigned medication orally. The specific medication and dosage are determined by the randomization process.

Possible medications include Elvanse (lisdexamfetamine dimesylate) in doses of 30 mg, 50 mg, or 70 mg, and Concerta (methylphenidate hydrochloride) in doses of 18 mg, 36 mg, or 54 mg.

4 evaluation after first cycle

At the end of the first 6-month cycle, an evaluation is conducted. This includes assessing ADHD symptoms using the Conners 3 questionnaire and monitoring any adverse events.

5 crossover to second treatment cycle

Participants switch to the other medication for the second 6-month treatment cycle. The process and dosages are similar to the first cycle.

6 evaluation after second cycle

After completing the second cycle, another evaluation is conducted. This includes a similar assessment of ADHD symptoms and adverse events as in the first cycle.

7 final assessment

A final assessment is performed to compare the effects of both medications on ADHD symptoms and diabetes management. This includes analyzing differences in symptom scores and glycemic control.

Who Can Join the Study?

Age between 8 and 16.5 years at the start of the study.
Diagnosed with Type 1 diabetes (T1D) based on certain clinical features, such as the presence of specific autoantibodies (like anti-GAD, ICA, IAA/IA2, ZnT8) or low levels of a substance called C-peptide. Diagnosis should follow the criteria of the Polish Diabetes Association and international guidelines, which include:
- Blood sugar level of 200 mg/dL or higher with symptoms like increased thirst, frequent urination, or weakness.
- Two fasting blood sugar tests showing levels of 126 mg/dL or higher.
- Blood sugar level of 200 mg/dL or higher during a specific test called an oral glucose load test.
- HbA1c level of 6.5% or higher. HbA1c is a test that shows average blood sugar levels over the past 2-3 months.
T1D must be managed with a treatment called functional intensive insulin therapy.
Must have had T1D for at least 12 months before joining the study.
Diagnosed with Attention-deficit hyperactivity disorder (ADHD) according to DSM-5 criteria, confirmed by a psychiatrist, or according to other recognized criteria in Poland.
Must have Polish citizenship and Polish health insurance.
For patients who can become pregnant and have started living with a partner, effective birth control must be used throughout the study. For those who have not started living with a partner, they must maintain sexual abstinence.

Who Cannot Join the Study?

Patients who do not have Type 1 diabetes or Attention-deficit hyperactivity disorder (ADHD) cannot participate. ADHD is a condition that affects attention and behavior.
Individuals who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Both males and females are eligible, so gender is not a reason for exclusion.
Individuals who are considered part of a vulnerable population may not be eligible. A vulnerable population includes people who might need extra protection in a study, like children or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland

Other Sites

Site Name	City	Country
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Mevkiib Uuanttpcrp Og Sprtbvi Krprmgoy Prmtwg	Katowice	Poland
Ukuirjcmurjewk Chugyby Krvzinfal	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.12.2022

Trial locations

Investigated drugs:

Lisdexamphetamine is a medication used in this trial to help manage symptoms of ADHD in pediatric patients. It works by affecting certain chemicals in the brain that contribute to hyperactivity and impulse control. This medication is being tested to see how well it helps children with both ADHD and type 1 diabetes.

Methylphenidate is another medication used in the trial for treating ADHD symptoms. It helps increase attention and decrease impulsiveness and hyperactivity in children. The trial aims to compare its effectiveness and safety with lisdexamphetamine in children who also have type 1 diabetes.

Investigated diseases:

Type 1 diabetes – This is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears during childhood or adolescence but can develop in adults. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. Over time, this leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Managing blood sugar levels is crucial to prevent complications.

Attention-deficit hyperactivity disorder – This is a neurodevelopmental disorder characterized by a persistent pattern of inattention, hyperactivity, and impulsivity that interferes with functioning or development. Symptoms often appear before the age of 12 and can continue into adulthood. Inattention may manifest as difficulty sustaining focus, not following through on tasks, or being easily distracted. Hyperactivity and impulsivity can include fidgeting, an inability to stay seated, excessive talking, or interrupting others. The disorder can affect academic, occupational, and social functioning. The severity and specific symptoms can vary widely among individuals.

Trial ID:

2023-506862-30-00

Protocol code:

LAMA/2021/1

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Lisdexamfetamine and Methylphenidate for Children with ADHD and Type 1 Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?