UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012234
Receipt number R000014307
Scientific Title The PRebiotics Effect on Endotoxinemia in type 2 Diabetes
Date of disclosure of the study information 2013/11/11
Last modified on 2022/05/27 14:57:24

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Basic information

Public title

The PRebiotics Effect on Endotoxinemia in type 2 Diabetes

Acronym

PREED

Scientific Title

The PRebiotics Effect on Endotoxinemia in type 2 Diabetes

Scientific Title:Acronym

PREED

Region

Japan


Condition

Condition

type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the effect of GOS on endotoxinemia in type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

serum LBP,LPS

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

GOS

Interventions/Control_2

placebo

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

type 2 diabetes treated over 3 months

Key exclusion criteria

patients prescribed alpha-GI and antibiotics

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kumiko
Middle name
Last name Hamano

Organization

Kantoh Rosai Hospital

Division name

diabetes and endoclinology

Zip code

211-8510

Address

Kanagawa-prefecture Kawasaki-city Nakahara-ku Kizukisumiyoshicho 1-1

TEL

044-411-3131

Email

teamdm@kantoh.rofuku.go.jp


Public contact

Name of contact person

1st name Hiroko
Middle name
Last name Kato

Organization

Kantoh Rosai Hospital

Division name

diabetes and endoclinology

Zip code

211-8510

Address

Kanagawa-prefecture Kawasaki-city Nakahara-ku Kizukisumiyoshicho 1-1

TEL

044-411-3131

Homepage URL


Email

teamdm@kantoh.rofuku.go.jp


Sponsor or person

Institute

Kantoh Rosai Hospital

Institute

Department

Personal name



Funding Source

Organization

Yakult

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kantoh Rosai Hospital IRB

Address

1-1 Kizukisumiyoshi,Nakahara, Kawasaki, Kangata, Japan

Tel

044-411-3131

Email

teamdm@kantoh.rofuku.go.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

関東労災病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 11 Day


Related information

URL releasing protocol

https://www.wageningenacademic.com/doi/abs/10.3920/BM2016.0230

Publication of results

Partially published


Result

URL related to results and publications

https://www.wageningenacademic.com/doi/abs/10.3920/BM2016.0230

Number of participants that the trial has enrolled

116

Results

Levels of FPG, HbA1c, ALT, and TG in DMAG were significantly higher than those in CG.

Results date posted

2022 Year 05 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Sex (male/female; n)14/16 29/11

Participant flow

Following recruitment, we asked CG and DMG subjects to submit fresh faecal samples to investigate gut microbiota and their metabolic products. We then took blood samples from all participants to measure various biochemical parameters, including LBP, LPS, IL-6, IL-10, and TNF-a. DMG were randomly assigned to receive either 10 g/d GOS syrup (Oligomate55N; Yakult Pharmaceutical Industry, Tokyo, Japan) or 10 g/d maltodextrin syrup as a placebo for 4 weeks (Supplementary Table S1). GOS and placebo had a similar package and taste, and both participants and main investigators remained blind until the end of this study. After 4 weeks of syrup intake, both the GOS group and placebo group provided faecal and blood samples, and the same parameters were measured again. Finally, all patients answered brief questionnaires about the frequency of consumption of yogurt and probiotic or prebiotic supplements.

Adverse events

none

Outcome measures

gut microbiota
Levels of FPG, HbA1c, ALT, and TG, LBP, LPS, IL-6, IL-10, and TNF-a

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 09 Month 11 Day

Date of IRB

2013 Year 12 Month 01 Day

Anticipated trial start date

2013 Year 12 Month 01 Day

Last follow-up date

2014 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 07 Day

Last modified on

2022 Year 05 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014307


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name