UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051500 |
|---|---|
| Receipt number | R000058753 |
| Scientific Title | A study of the relationship between diabetic neuropathy and abnormal diurnal variation of blood pressure |
| Date of disclosure of the study information | 2023/07/02 |
| Last modified on | 2023/07/02 00:44:13 |
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Basic information
Public title
A study of the relationship between diabetic neuropathy and abnormal diurnal variation of blood pressure
Acronym
A study of the relationship between diabetic neuropathy and abnormal diurnal variation of blood pressure
Scientific Title
A study of the relationship between diabetic neuropathy and abnormal diurnal variation of blood pressure
Scientific Title:Acronym
A study of the relationship between diabetic neuropathy and abnormal diurnal variation of blood pressure
Region
| Japan |
Condition
Condition
diabetic neuropathy
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the proportion of patients with abnormal diurnal variation of blood pressure between the electrophysiological severity and clinical stage of diabetic neuropathy, and to examine the association between diabetic neuropathy and abnormal diurnal variation of blood pressure.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients with abnormal diurnal variation of blood pressure of Riser type in electrophysiological severity and clinical stage of diabetic neuropathy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes treated as inpatients at the Department of Diabetes and Endocrinology, Kagoshima University Hospital from April 2015 to October 2018
Key exclusion criteria
1) Cases complicated by peripheral neuropathy due to causes other than endocrine disease, spinal disease, or diabetes mellitus
2) Cases in which secondary hypertension is suspected
3) Patients who have not undergone nerve conduction studies or 24-hour ambulatory blood pressure monitoring
4) Cases in which the physician determines that the patient is not suitable for incorporation.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Nishio |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Diabetes and Endocrine Medicine
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Kagoshima Prefecture 890-8544, Japan
TEL
099-275-6478
dmen6478@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Dai |
| Middle name | |
| Last name | Yamagami |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Diabetes and Endocrine Medicine
Zip code
890-8544
Address
8-35-1, Sakuragaoka, Kagoshima, Kagoshima Prefecture 890-8544, Japan
TEL
099-275-6478
Homepage URL
k3542989@kadai.jp
Sponsor or person
Institute
Department of Diabetes and Endocrine Medicine, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
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
Ethics Committee on Epidemiological Studies, Kagoshima University
Address
8-35-1, Sakuragaoka, Kagoshima, Kagoshima Prefecture 890-8544, Japan
Tel
099-275-6090
isgskkrs@kuas.kagoshima-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
| 2023 | Year | 07 | Month | 02 | 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
154
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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study
To analyze the association between the progression of diabetic neuropathy and abnormal diurnal variation of blood pressure.
Management information
Registered date
| 2023 | Year | 07 | Month | 02 | Day |
Last modified on
| 2023 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058753
