UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022336
Receipt number R000025740
Scientific Title Observational study of metabolic factors associated with eGFR decline in participants with health checkups
Date of disclosure of the study information 2016/05/20
Last modified on 2017/05/22 14:57:11

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Basic information

Public title

Observational study of metabolic factors associated with eGFR decline in participants with health checkups

Acronym

Observational study of metabolic factors associated with eGFR decline in participants with health checkups

Scientific Title

Observational study of metabolic factors associated with eGFR decline in participants with health checkups

Scientific Title:Acronym

Observational study of metabolic factors associated with eGFR decline in participants with health checkups

Region

Japan


Condition

Condition

chronic kidney disease, lifestyle-related disease

Classification by specialty

Medicine in general Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to investigate the factors associated with an eGFR decline in one year, especially metabolic factors which are strongly affected by individual lifestyle, in Japanese people who received annual health checkup.

Basic objectives2

Others

Basic objectives -Others

Observational study

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

change in eGFR

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Individuals who received at least two annual health checkups in Keio University Hospital.

Key exclusion criteria

Individuals with eGFR < 15 ml/min/1.73m2 (CKD stage G5) are excluded from the study.

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michiyo Takayama

Organization

Keio University School of Medicine

Division name

Preventive Medicine

Zip code


Address

35 Shinanomachi Shinjuku-ku Tokyo Japan

TEL

03-3353-1211

Email

michiyo@z6.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaori Hayashi

Organization

Keio University School of Medicine

Division name

Preventive Medicine

Zip code


Address

35 Shinanomachi Shinjuku-ku Tokyo Japan

TEL

03-3353-1211

Homepage URL


Email

kaorihayashi@keio.jp


Sponsor or person

Institute

Department of Preventive Medicine, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 05 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Low HDL-C and ApoA1 levels significantly correlated with eGFR decline in a short period of one year. Metabolic syndrome also showed a significant association with eGFR decline. This study suggests the importance of hypertension and low HDL-C in the effect of metabolic syndrome on eGFR decline rather than obesity in non-CKD population.

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

2013 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information

Study design: Cross-sectional study. Individuals who received health checkup from Jan 1st in 2013 and did not meet the exclusion criteria have been enrolled. We examined blood pressure, body mass index (BMI, kg/m2), and waist circumference at the level of the navel during minimal respiration. All participants completed a self-administered questionnaire which documented medical history, medication, smoking habit, alcohol consumption habit, the frequency and intensity of daily exercise, eating habits, and sleeping habit. Serum makers including triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), lipoprotein A (Lp(a)), apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), glucose, hemoglobin A1c (HbA1c), homeostatic model assessment of insulin resistance (HOMA-R), uric acid (UA), and highly-sensitive C reactive protein (hs-CRP) were measured. We examined urinary protein and blood excretion in urine samples using dipstick testing. Visceral fat area (VFA) was measured at the navel level using a single-slice CT scan.


Management information

Registered date

2016 Year 05 Month 17 Day

Last modified on

2017 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025740


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name