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Идёт набор NCT05998772

Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease

— Наблюдательное Parkinson Disease Nutritional and Metabolic Diseases Sugar Intake

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Oral Glucose Tolerance Test, Placebo Oral Glucose Tolerance Test.
Кому может быть актуально
Состояния в реестре: Parkinson Disease, Nutritional and Metabolic Diseases, Sugar Intake. Базовые параметры: 50 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Many patients with Parkinson's Disease (PD) report an increased consumption of fast-acting sugars. This tendency to consume sweet, high-sugar foods occurs in some patients even before the onset of cardinal motor symptoms. Some recent studies have demonstrated that PD patients have an increased consumption of fast-acting carbohydrates compared to healthy controls. However, the reason for this change in eating behavior has not yet been adequately explained. It is discussed that the increased sugar intake leads to an increased dopamine release in the brain via an increase in insulin and thus to an improvement in clinical symptoms. This study investigates the influence of fast-acting carbohydrates on insulin and glucose blood levels as well as motor and non-motor symptoms in patients with PD using an oral glucose tolerance test and a placebo oral glucose tolerance test in a crossover design.

Вмешательства

  • Диагностический тест Oral Glucose Tolerance Test
    Application of 82,5 g of glucose monohydrate solved in 300ml water
  • Другое Placebo Oral Glucose Tolerance Test
    Application of 125mg sucralose solved in 300ml water

Первичные конечные точки

  • Concentration of Insulin in µU/mL [Срок оценки: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application]
  • Motor function [Срок оценки: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60 and 120 minutes after application]
  • Concentration of Blood Glucose in mg/dL [Срок оценки: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application]
Вторичные конечные точки (1)
  • Cognitive function [Срок оценки: immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after application]

Критерии участия

Критерии включения

  • Diagnosis of Parkinson's Disease, stage Hoehn \& Yahr 1.5-3
  • Ability to pause antiparkinsonian medication in the morning without relevant impairment
  • Capacity to give consent (determined in doubt by two independent neurologists, MOCA ≥18) and written informed consent.
  • Patients are between 50 and 80 years of age, with exceptions for a maximum of 5 additional patients enrolled per group
  • For stratification into patients with and without sweet craving, a 3-day dietary protocol should be completed once by the patients
  • Group I: increased hunger for sweets.
  • Group II: no increased hunger for sweets.

For the stratification into patients with and without increased hunger for sweets, participants are asked to answer the following questions:

  • Do you have sudden attacks of cravings for sweets?
  • Would you say that your consumption of sweet food has increased in recent years?
  • Would you describe your consumption of sugary food as increased or excessive?

If one of the questions is answered with yes, participants will be assigned to group I, if all questions are answered with no, participants will be assigned to group II.

Критерии исключения

  • Other significant neurological diseases primarily affecting the central nervous system (e.g., multiple sclerosis)
  • Diagnosis of diabetes mellitus or prediabetes
  • Use of medications that affect glucose metabolism, such as antidiabetics, glucocorticoids, ciclosporin, tacrolimus, sirolimus, beta-blockers, thiazide diuretics, beta-2 adrenoreceptor agonists, theophylline, Clozapine, olanzapine, paliperidone, quetiapine, risperidone, tricyclic antidepressants, mirtazapine, mianserin, carbamazepine, gabapentin, pregabalin, valproic acid, lithium, antiretroviral drugs, statins
  • cardiac or brain pacemakers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-кроссовер

Центры проведения

Германия · 1 центр
  • Department for Neurology, University of Kiel — Kiel

Идентификаторы

NCT: NCT05998772 · D 537/23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗