UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005405
Receipt number R000006416
Scientific Title The association between young adults with very low birth weight and lifestyle disease
Date of disclosure of the study information 2011/04/08
Last modified on 2011/04/08 11:04:11

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Basic information

Public title

The association between young adults with very low birth weight and lifestyle disease

Acronym

Very low birth weight and lifestyle disease

Scientific Title

The association between young adults with very low birth weight and lifestyle disease

Scientific Title:Acronym

Very low birth weight and lifestyle disease

Region

Japan


Condition

Condition

diabetes, hypertension, CKD, dyslipidemia, thyroid dysfunction

Classification by specialty

Medicine in general Endocrinology and Metabolism Pediatrics
Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To examin the metabolic state in young adults with very low birth weight and the genetic factors affecting metabolic disorder and low birth weight.

Basic objectives2

Others

Basic objectives -Others

To examin the glucose metabolism in young adults with very low birth weight and the genotype affecting metabolic disorder and low birth weight.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

plasma glucose and insulin levels during OGTT

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Gene Maneuver

Interventions/Control_1

Collecting blood
Peripheral blood to draw DNA
OGTT

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

19 years-old <=

Age-upper limit

30 years-old >=

Gender

Male and Female

Key inclusion criteria

Subjects who had been born with very low birth weight between 1980 and 1990 and treated at the neonatal intensive care unit of Seirei Hamamatsu General Hospital

Key exclusion criteria

Severe neurodevelopmental impairment

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryosuke Sato

Organization

Seirei Hamamatsu General Hospital
Hamamatsu University School of Medicine

Division name

division of Endocrinology and Metabolism

Zip code


Address

2-12-12 Sumiyoshi, naka-ku, Hamamatsu, Shizuoka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Seirei Hamamatsu General Hospital

Division name

Clinical trial center

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Seirei Hamamatsu General Hospital

Institute

Department

Personal name



Funding Source

Organization

Seirei Hamamatsu General 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


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

2011 Year 04 Month 08 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

Open public recruiting

Date of protocol fixation

2010 Year 07 Month 03 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 04 Month 08 Day

Last modified on

2011 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006416


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name