Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorUniversity Hospital Schleswig-Holstein
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population includes Parkinson's Disease patients with and without sweet cravings. Recruitment of patients takes place in the outpatient clinic for movement disorders at the University of Kiel.
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Oral Glucose Tolerance Test
Diagnostic testApplication of 82,5 g of glucose monohydrate solved in 300ml water
Placebo Oral Glucose Tolerance Test
Other interventionApplication of 125mg sucralose solved in 300ml water
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: PD patients with craving for sweets2 interventions
Group B: PD patients without craving for sweets2 interventions
Trial outcomes
Primary outcomes
1
Concentration of Insulin in µU/mL
Blood value
Time frame
immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application2
Motor function
assessed by Unified Parkinson's Disease Rating Scale Part III, 0-132 points, higher points indicate worse motor function
Time frame
immediately before Application of oral glucose tolerance test and placebo as well as 30, 60 and 120 minutes after application3
Concentration of Blood Glucose in mg/dL
Blood value
Time frame
immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after applicationSecondary outcomes
1
Cognitive function
assessed by Montreal-Cognitive-Assessment-Test (MoCa), 0-30 points, higher points indicate better cognitive function
Time frame
immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after applicationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Schleswig-Holstein
Lead sponsor
University of Kiel
Collaborator
Source ClinicalTrials.gov