Parkinson DiseasePaGluNCT05998772
Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease
An observational study of Parkinson Disease and Nutritional and Metabolic Diseases, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease, Nutritional and Metabolic Diseases, Sugar Intake
- What is being tested?
- Oral Glucose Tolerance Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Julienne Haas, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department for Neurology, University of Kiel
Kiel, 24118
Eva Schäffer, Dr., 004943150023983, eva.schaeffer@uksh.de
About this study
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.
- Being tested
- Oral Glucose Tolerance Test, Placebo Oral Glucose Tolerance Test
- Medical subject headings
- Parkinson Disease, Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance TestDiagnostic test
Application of 82,5 g of glucose monohydrate solved in 300ml water
Placebo Oral Glucose Tolerance TestOther
Application of 125mg sucralose solved in 300ml water
| Study group | Role | What they receive |
|---|---|---|
| PD patients with craving for sweets | Not described Receives: Diagnostic Test: Oral Glucose Tolerance Test; Other: Placebo Oral Glucose Tolerance Test | |
| PD patients without craving for sweets | Not described Receives: Diagnostic Test: Oral Glucose Tolerance Test; Other: Placebo Oral Glucose Tolerance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Insulin in µU/mL
Blood value
Measured: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application
Motor function
assessed by Unified Parkinson's Disease Rating Scale Part III, 0-132 points, higher points indicate worse motor function
Measured: 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
Blood value
Measured: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application
Secondary outcomes (1)
Cognitive function
assessed by Montreal-Cognitive-Assessment-Test (MoCa), 0-30 points, higher points indicate better cognitive function
Measured: immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Sep 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel
- Responsible party
- Principal investigator, Eva Schaeffer, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998772
- Sponsor's protocol ID
- D 537/23
- Acronym
- PaGlu
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05998772
- Acronym / sponsor ID
- PaGlu / D 537/23
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University of Kiel
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD patients with craving for sweets | – | Diagnostic Test: Oral Glucose Tolerance Test, Other: Placebo Oral Glucose Tolerance Test |
| PD patients without craving for sweets | – | Diagnostic Test: Oral Glucose Tolerance Test, Other: Placebo Oral Glucose Tolerance Test |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose Tolerance TestApplication of 82,5 g of glucose monohydrate solved in 300ml water | Diagnostic test | PD patients with craving for sweets, PD patients without craving for sweets |
| Placebo Oral Glucose Tolerance TestApplication of 125mg sucralose solved in 300ml water | Other | PD patients with craving for sweets, PD patients without craving for sweets |
Primary outcome
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
Blood value
Motor function
Time frame: 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
Time frame: immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application
Blood value
1 secondary outcome
Cognitive function
Time frame: immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julienne Haas, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Nutritional and Metabolic Diseases, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Schäffer, MD (004943150023983, eva.schaeffer@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.