UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039791 |
|---|---|
| Receipt number | R000045377 |
| Scientific Title | Impact of primary aldosteronism on renal function in patients with type 2 diabetes |
| Date of disclosure of the study information | 2020/03/12 |
| Last modified on | 2020/08/12 10:23:47 |
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Basic information
Public title
A research for effects of primary aldosteronism on renal function in patients with type 2 diabetes
Acronym
Impact of primary aldosteronism on renal function in patients with type 2 diabetes
Scientific Title
Impact of primary aldosteronism on renal function in patients with type 2 diabetes
Scientific Title:Acronym
Impact of primary aldosteronism on renal function in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus, primary aldosteronism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Renal dysfunction may quickly progress in patients with type 2 diabetes (T2DM), when accompanied hypertension. However, whether primary aldosteronism (PA), which autonomously over-secretes aldosterone, causes additional renal damage in patients with T2DM is unclear. We evaluated the impact of PA on renal function in patients with T2DM.
Basic objectives2
Others
Basic objectives -Others
Clinical charactaristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
estimated glomerular filtration rate
Key secondary outcomes
urine albumin-to-creatinine ratio
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All outpatients with type 2 diabetes who visited our hospital between April 2017 and March 2018.
Key exclusion criteria
Patients with type 1 diabetes, gestational diabetes, specific types of diabetes, Cushing's syndrome, renal cell carcinoma, glomerulonephritis, and untreated primary aldosteronism.
Patients with estimated glomerular filtration rate < 15 mL/min/1.73m2.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Katsuragawa |
Organization
Yokohama Rosai Hospital
Division name
Endocrinology and Diabetes Center
Zip code
2220036
Address
3211 Kozukue-cho, Kouhoku-ku, Yokohama, Kanagawa, Japan.
TEL
+81-45-474-8111
sho.k.2876@gmail.com
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Katsuragawa |
Organization
Yokohama Rosai Hospital
Division name
Endocrinology and Diabetes Center
Zip code
2220036
Address
3211 Kozukue-cho, Kouhoku-ku, Yokohama, Kanagawa, Japan.
TEL
+81-45-474-8111
Homepage URL
sho.k.2876@gmail.com
Sponsor or person
Institute
Yokohama Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Non
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
Yokohama Rosai Hospital
Address
3211 Kozukue-cho, Kouhoku-ku, Yokohama, Kanagawa, Japan.
Tel
+81-45-474-8111
sho.k.2876@gmail.com
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
| 2020 | Year | 03 | Month | 12 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 08 | Month | 12 | Day |
Other
Other related information
A retrospective review of the electronic medical records of all outpatients who visited our hospital between April 2017 and March 2018 will be carried out. We will extract profiles of the patients, disease names, examination findings (estimated glomerular filtration rate [eGFR], urine albumin-to-creatinine ratio [UACR], and glycated hemoglobin [HbA1c]), physical data (height, weight and body mass index [BMI]), and prescriptions from electronic medical records. Disease names will be searched by using the International Classification of Diseases, Tenth Revisions codes.
We will extract data of patients with type 2 diabetes (T2DM), then divide these patients into two groups; patients with primary aldosteronism (PA) who underwent PA treatment (PA group), and patients without PA (non-PA group). We will compare renal function between these two groups and will examine factors that affected renal function.
Moreover, in the PA group, we will manually confirm individual electronic medical records and will extract data for eGFR, UACR, plasma renin activity, and plasma aldosterone concentration before PA treatment, and other information described in the text, including age at the time of diagnosis of hypertension and T2DM, age at the start of PA treatment, and smoking history, to perform further analysis.
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045377
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