NCT05998772 Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease
| NCT ID | NCT05998772 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Schleswig-Holstein |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-09-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: 1. Do you have sudden attacks of cravings for sweets? 2. Would you say that your consumption of sweet food has increased in recent years? 3. 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05998772 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05998772 currently recruiting?
Yes, NCT05998772 is actively recruiting participants. Contact the research team at eva.schaeffer@uksh.de for enrollment information.
Where is the NCT05998772 trial being conducted?
This trial is being conducted at Kiel, Germany.
Who is sponsoring the NCT05998772 clinical trial?
NCT05998772 is sponsored by University Hospital Schleswig-Holstein. The trial plans to enroll 50 participants.
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