UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037135 |
|---|---|
| Receipt number | R000042323 |
| Scientific Title | Prospective voluntary clinical research that supports carbohydrate restriction and aerobic exercise and supports physical condition improvement for untreated patients who are pointed out hyperuricemia by medical checkups. |
| Date of disclosure of the study information | 2019/06/23 |
| Last modified on | 2019/06/22 19:45:42 |
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Basic information
Public title
Prospective voluntary clinical research that supports carbohydrate restriction and aerobic exercise and supports physical condition improvement for untreated patients who are pointed out hyperuricemia by medical checkups.
Acronym
Prospective voluntary clinical research that supports carbohydrate restriction and aerobic exercise and supports physical condition improvement for untreated patients who are pointed out hyperuricemia by medical checkups.
Scientific Title
Prospective voluntary clinical research that supports carbohydrate restriction and aerobic exercise and supports physical condition improvement for untreated patients who are pointed out hyperuricemia by medical checkups.
Scientific Title:Acronym
Prospective clinical research that supports physical condition improvement for untreated hyperuricemia.
Region
| Japan |
Condition
Condition
Hyperuricemia
Classification by specialty
| Medicine in general | Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will conduct carbohydrate restriction and appropriate aerobic exercise guidance interventions, and compare changes in uric acid levels with diet guidance alone. In addition, we examine each various factors how the intervention affecting the fluctuation of uric acid levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in UA value at study start and 6 months after
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
(1)Conventional dietary guidance only group
Interventions/Control_2
(2)Aerobic exercise group after intiatinon of carbohydrate restriction diet
Interventions/Control_3
(3)Carbohydrate restriction after initiation of aerobic exercise
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Target patients who meet all the following criteria
1) Hyperuricemia patients (untreated patients: UA value 7 mg / dL or more)
2) Patients of 20 years or older at the time of obtaining consent (regardless of gender)
3) Patients who obtained written consent by their own free will after receiving sufficient explanation for participating in this study
4) Patients who have used smartphone usually and have a email address
Key exclusion criteria
Patients who conflict with any of the following will not be included in this study
1) Patients who have already received drug treatment for hyperuricemia
2) Patients who received treatment for hyperuric acid treatment up to 3 months ago and have been discontinued.
3) Patients who have received medical treatment such as diabetes (including boundary type)
4) Patients with a history of myocardial infarction
5) Patients with a history of coronary revascularization (PCI or CABG)
6) Patients with unstable angina
7) Patients with a history of cerebrovascular disease (except asymptomatic lacunar infarction)
8) Patients who have been hospitalized for heart failure
9) Patients with severe liver disease (AST (GOT) or ALT (GPT)> 100 U)
10) Patients with severe renal disease (BUN 25 mg / dL or more or serum creatinine 2.0 mg / dL or more)
11) Pregnant and nursing women
12) Any patient who the research director has judged inappropriate as a research subject
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | YOSHIDA |
Organization
Sendai Tokushukai Hospital
Division name
orthopedic surgery
Zip code
980-0011
Address
15 kagosawa nanakita ixumi-ku sendai city
TEL
022-372-1110
syoshida@miyagi.med.or.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | YOSHIDA |
Organization
Sendai Tokushukai Hospital
Division name
orthopedic surgery
Zip code
980-0011
Address
15 kagosawa nanakita ixumi-ku sendai city
TEL
022-372-1110
Homepage URL
syoshida@miyagi.med.or.jp
Sponsor or person
Institute
Sendai Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Sendai Tokushukai Hospital
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
Sendai Tokushukai Hospital
Address
15 kagosawa nanakita ixumi-ku sendai city
Tel
022-372-1110
syoshida@miyagi.med.or.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
| 2019 | Year | 06 | Month | 23 | 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
| 2019 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2019 | Year | 06 | Month | 22 | Day |
Last modified on
| 2019 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042323
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
