UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058221 |
|---|---|
| Receipt number | R000066564 |
| Scientific Title | Elucidation of Energy Metabolism Mechanisms in Parkinson Disease Using Doubly Labeled Water |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/06/19 14:49:27 |
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Basic information
Public title
Elucidation of Energy Metabolism Mechanisms in Parkinson Disease Using Doubly Labeled Water
Acronym
Elucidation of Energy Metabolism Mechanisms in Parkinson Disease
Scientific Title
Elucidation of Energy Metabolism Mechanisms in Parkinson Disease Using Doubly Labeled Water
Scientific Title:Acronym
Elucidation of Energy Metabolism Mechanisms in Parkinson Disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure energy expenditure in Parkinson disease
Basic objectives2
Others
Basic objectives -Others
To measure energy excretion in Parkinson disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total daily energy expenditure measured by the elimination rates of 18O and 2H.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
On the first day of the study, participants will ingest doubly labeled water containing stable isotopes of oxygen and hydrogen. The volume administered will be approximately 1.5 g per kilogram of body weight, depending on the each body size.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible participants will be male or female patients diagnosed with Parkinson disease HY up to IV, aged 20 years or older and under 80 years, who have provided written informed consent to participate in this study.
Prior to obtaining consent, participants will be provided with a detailed explanation of the study using an information sheet, including a description of the procedures, devices, and facilities involved, to ensure full understanding.
Inclusion criteria:
Patients diagnosed with Parkinson disease who visit the Department of Neurology at Takagi Hospital or Fukuoka Sanno Hospital between April 1, 2025, and March 31, 2026.
Patients capable of providing written informed consent of their own free will.
Patients aged 20 years or older and under 80 years at the time of consent.
Disease severity classified as H&Y stage up to IV.
No restriction based on sex.
No restriction based on inpatient or outpatient status.
Key exclusion criteria
Participants will be excluded from the study if they meet any of the following conditions
Individuals unable to comply with the study protocol, including proper sample storage and scheduled outpatient visits.
Individuals with comorbid gastrointestinal disorders that cause malabsorption.
Individuals with comorbid endocrine disorders that affect energy intake.
Individuals with comorbid psychiatric disorders that result in pathological appetite loss.
Individuals with comorbid neoplastic diseases.
Individuals with severe renal impairment.
Individuals with cognitive impairment.
Individuals in a state of starvation.
Individuals with a BMI of 30 or higher.
Individuals using implanted medical devices such as deep brain stimulators.
Individuals with extremely irregular dietary habits.
Individuals currently participating in, or intending to participate in, other clinical trials involving the consumption of food or medications, or the application of cosmetics or pharmaceuticals.
Individuals with habitual alcohol consumption or smoking that cannot be controlled during the study period.
Any individual who, despite obtaining the attending physicians consent, is deemed by the principal investigator to be unsuitable for safe participation in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Fujioka |
Organization
Inernational University of Health and Welfare
Division name
Department of Neurology
Zip code
831-0016
Address
141-11, Sakemi, Okawa, Fukuoka
TEL
0944-87-0001
s.fujioka@ihwg.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Fujioka |
Organization
Inernational University of Health and Welfare
Division name
Department of Neurology
Zip code
831-0016
Address
141-11, Sakemi, Okawa, Fukuoka
TEL
0944-87-0001
Homepage URL
s.fujioka@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of the Institutional Review Board, Kyushu Area, International University of Health and Welfare
Address
182-2 Enokizu, Okawa City, Fukuoka, Japan
Tel
092-407-0434
q-rinri@ihwg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066564
