UMIN-CTR Clinical Trial

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
Email	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
Email	syoshida@miyagi.med.or.jp

Sponsor
Institute	Sendai Tokushukai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042323