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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039791
Receipt No. 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

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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
Email 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
Email sho.k.2876@gmail.com

Sponsor
Institute Yokohama Rosai Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045377

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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