UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053564 |
|---|---|
| Receipt number | R000061120 |
| Scientific Title | Randomised crossover controlled trial on the effect of underwater recumbent ergometer exercise on renal artery blood flow in people with diabetes mellitus. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/02/07 13:20:11 |
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Basic information
Public title
Randomised crossover controlled trial on the effect of underwater recumbent ergometer exercise on renal artery blood flow in people with diabetes mellitus.
Acronym
The study of the effect of underwater recumbent ergometer exercise performed by people with diabetes mellitus on renal arterial blood flow.
Scientific Title
Randomised crossover controlled trial on the effect of underwater recumbent ergometer exercise on renal artery blood flow in people with diabetes mellitus.
Scientific Title:Acronym
Randomised crossover controlled trial on the effect of underwater recumbent ergometer exercise on renal artery blood flow in people with diabetes mellitus.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of underwater recumbent ergometer exercise on renal artery blood flow in people with diabetes mellitus.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean blood flow velocity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Underwater recumbent ergometer exercise for 15min
Interventions/Control_2
recumbent ergometer exercise on land for 15min
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients with diabetes whose age is between 40 and 65 years at the time written consent is obtained.
(2) Have no exercise restrictions as directed by their doctor
(3) Patients who have given their free written consent to participate in the study
Key exclusion criteria
(1) Those with lower limb bone and joint disease or / and ischemic heart disease or cardiopulmonary impairment, which makes it difficult to perform the pedaling exercises used in this study
(2) Persons with an HbA1c of 8.0% or more or / and a fasting blood glucose level of 250 mg/dL or more or a positive urine ketone on a recent blood test in the last month
(3) Post renal transplantation or those whose renal function is in the obvious nephropathy phase to dialysis phase
(4) Persons presenting with autonomic neuropathy
(5) Persons presenting with advanced retinopathy beyond simple retinopathy
(6) Persons with unstable blood pressure control
(7) Persons with complications of psychiatric or cognitive disorders requiring treatment
(8) Pregnant women
(9) Persons with a history of major surgery within 180 days prior to obtaining consent
(10) Persons with acute generalized infectious diseases requiring treatment
(11) Persons with a BMI of 25.0 kg/m2 or more
(12) Persons who smoke
(13) Persons who have an allergic reaction to zinc (synthetic acrylic fiber) used for the adhesive surface of ECG electrodes
(14) Other patients considered unsuitable by the person in responsible charge of the study
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Hisafumi |
| Middle name | |
| Last name | YASUDA |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Public Health
Zip code
6540142
Address
7-10-2, Suma, Kobe, Hyogo, JAPAN
TEL
078-792-2555
yasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Public Health
Zip code
6540142
Address
7-10-2, Tomogaoka, Suma, Kobe, Hyogo, JAPAN
TEL
078-792-2555
Homepage URL
onoku@tiger.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital, intervention research ethical review board
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, JAPAN
Tel
078-382-6669
kainyu@med.kobe-u.ac.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
| 2024 | Year | 04 | 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
| 2024 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061120
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