PaGlu: Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PD patients with craving for sweets
|
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
|
| PD patients without craving for sweets
|
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
|
Outcome Measures
Primary Outcome Measures
- Concentration of Insulin in µU/mL [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 [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 [immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application]
Blood value
Secondary Outcome Measures
- Cognitive function [immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after application]
assessed by Montreal-Cognitive-Assessment-Test (MoCa), 0-30 points, higher points indicate better cognitive function
Eligibility Criteria
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. Increased hunger for sweets in group I is defined as follows: >= 20 energy percent (En%) by total sugar per day; In group II, no increased hunger for sweets is defined as follows: <= 10En% by total sugar per day.
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department for Neurology, University of Kiel | Kiel | Germany | 24118 |
Sponsors and Collaborators
- University Hospital Schleswig-Holstein
- University of Kiel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D 537/23