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

Parkinson Disease Clinical Trial

— PaGlu  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998772
• Other study ID #: D 537/23
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: University Hospital Schleswig-Holstein
• Contact: Eva Schäffer, MD
• Phone: 004943150023983
• Email: eva.schaeffer[@]uksh.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Parkinson Disease
• Sugar Intake

Intervention

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

Locations

Country	Name	City	State
Germany	Department for Neurology, University of Kiel	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein	University of Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Insulin in µU/mL	Blood value	immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application
Primary	Motor function	assessed by Unified Parkinson's Disease Rating Scale Part III, 0-132 points, higher points indicate worse motor function	immediately before Application of oral glucose tolerance test and placebo as well as 30, 60 and 120 minutes after application
Primary	Concentration of Blood Glucose in mg/dL	Blood value	immediately before Application of oral glucose tolerance test and placebo as well as 30, 60, 90 and 120 minutes after application
Secondary	Cognitive function	assessed by Montreal-Cognitive-Assessment-Test (MoCa), 0-30 points, higher points indicate better cognitive function	immediately before Application of oral glucose tolerance test and placebo as well as 60 minutes after application