Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Concentration of Insulin in µU/mL
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Concentration of Insulin in µU/mL
时间窗: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application
Blood value
Motor function
时间窗: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60 and 120 minutes after application
assessed by Unified Parkinson's Disease Rating Scale Part III, 0-132 points, higher points indicate worse motor function
Concentration of Blood Glucose in mg/dL
时间窗: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application
Blood value
次要结局
- Cognitive function(immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after application)
研究者
Eva Schaeffer
Principal Investigator
University Hospital Schleswig-Holstein