Last updated: December 19, 2023
Sponsor: University Hospital Schleswig-Holstein
Overall Status: Active - Recruiting
Phase
N/A
Condition
Metabolic Disorders
Treatment
Oral Glucose Tolerance Test
Placebo Oral Glucose Tolerance Test
Clinical Study ID
NCT05998772
D 537/23
Ages 50-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of Parkinson's Disease, stage Hoehn & Yahr 1.5-3
- Ability to pause antiparkinsonian medication in the morning without relevantimpairment
- 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 5additional patients enrolled per group
- For stratification into patients with and without sweet craving, a 3-day dietaryprotocol 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, ifall questions are answered with no, participants will be assigned to group II.
Exclusion
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, thiazidediuretics, 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
Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Oral Glucose Tolerance Test
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
July 31, 2024
Connect with a study center
Department for Neurology, University of Kiel
Kiel, 24118
GermanyActive - Recruiting
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