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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05998772
Other study ID # D 537/23
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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