UMIN-CTR Clinical Trial

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