Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Glucose Tolerance Test, Placebo Oral Glucose Tolerance Test.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Nutritional and Metabolic Diseases, Sugar Intake. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Oral Glucose Tolerance Test
Application of 82,5 g of glucose monohydrate solved in 300ml water - Other Placebo Oral Glucose Tolerance Test
Application of 125mg sucralose solved in 300ml water
Primary outcome measures
- Concentration of Insulin in µU/mL [Time frame: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application]
- Motor function [Time frame: 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 [Time frame: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application]
Secondary outcome measures (1)
- Cognitive function [Time frame: immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after application]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Germany · 1 center
- Department for Neurology, University of Kiel — Kiel
Identifiers
NCT: NCT05998772 · D 537/23