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NCT Number: NCT05998772

Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department for Neurology, University of Kiel

Kiel, 24118, Germany

Location status: Recruiting

Location contact

Eva Schäffer, Dr.

CONTACT

[email protected]

004943150023983

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral glucose tolerance test

Diagnostic Test

Application of 82,5 g of glucose monohydrate solved in 300ml water

Placebo Oral Glucose Tolerance Test

Other

Application of 125mg sucralose solved in 300ml water

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Cognitive function

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Schäffer, MD

CONTACT

[email protected]

004943150023983

Julienne Haas, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • University of Kiel

Registry information

Acronym: PaGlu

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2023
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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