UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034336
Receipt number R000039146
Scientific Title Relationship between unaware hypoglycemia and physical performance in patients with chronic kidney disease
Date of disclosure of the study information 2018/10/01
Last modified on 2023/04/07 18:42:40

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Basic information

Public title

Relationship between unaware hypoglycemia and physical performance in patients with chronic kidney disease

Acronym

Relationship between unaware hypoglycemia and physical performance in patients with chronic kidney disease

Scientific Title

Relationship between unaware hypoglycemia and physical performance in patients with chronic kidney disease

Scientific Title:Acronym

Relationship between unaware hypoglycemia and physical performance in patients with chronic kidney disease

Region

Japan


Condition

Condition

Chronic kidney disease

Classification by specialty

Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation on the frequency of unconscious hypoglycemia in chronic kidney disease and its involvement in cardiovascular disease development and physical performance decline.

Basic objectives2

Others

Basic objectives -Others

Epidemiological Observation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency of unconscious hypoglycemia, and
the association with the onset of cardiovascular disease in the past two year and frequency of recurrent falls and fractures.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Chronic kidney disease patients with reduced glomerular filtration volume of 60 ml / min or less and those under dialysis treatment, with and without diabetes.

Key exclusion criteria

cachectic state of malignancy
progressed liver dysfunction
pregnancy
stage 3-4 cardiac failure
active infection

Target sample size

340


Research contact person

Name of lead principal investigator

1st name Yasuyuki
Middle name
Last name Ushiogi

Organization

Fukui-Saiseikai Hospital

Division name

Nephrology

Zip code

918-8503

Address

Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan

TEL

0776-23-1111

Email

ushiogi.yasuyuki3001@fukui.saiseikai.or.jp


Public contact

Name of contact person

1st name Yasuyuki
Middle name
Last name Ushiogi

Organization

Fukui-Saiseikai Hospital

Division name

Nephrology

Zip code

918-8503

Address

Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan

TEL

0776-23-1111

Homepage URL


Email

ushiogi.yasuyuki3001@fukui.saiseikai.or.jp


Sponsor or person

Institute

Fukui-Saiseikai Hospital

Institute

Department

Personal name



Funding Source

Organization

Fukui-Saiseikai Hospital

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

Saiseikai-hosp. Ethics Review Board

Address

Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan

Tel

0776-23-1111

Email

shp@fukui.saiseikai.or.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

2018 Year 10 Month 01 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

No longer recruiting

Date of protocol fixation

2018 Year 05 Month 01 Day

Date of IRB

2018 Year 05 Month 10 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2024 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cross sectional study of single outpatient patients


Management information

Registered date

2018 Year 10 Month 01 Day

Last modified on

2023 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039146


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name