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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007899
Receipt No. R000009281
Scientific Title The effect of Bifidobacterium on DPP-4 inhibitor in T2DM patients
Date of disclosure of the study information 2012/05/07
Last modified on 2019/05/13

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Basic information
Public title The effect of Bifidobacterium on DPP-4 inhibitor in T2DM patients
Acronym ADD-1
Scientific Title The effect of Bifidobacterium on DPP-4 inhibitor in T2DM patients
Scientific Title:Acronym ADD-1
Region
Japan

Condition
Condition Type 2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of Bifidobacterium on DPP-4 inhibitor on the glucose metabolism including GLP-1 and glucagon concentration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c and glycoalbumin concentration after Bifidobacterium treatment
Key secondary outcomes Bacterial flora
lipid profile
incidence of hypoglycemia
Short chain fatty acid

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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)outpatients and inpatients who take DPP-4 Inhibitor with a diet and moderate exercise more than two months
2)20<=Age<80
3)patients who agree to join the study
Key exclusion criteria 1)past history of the allergy to Bifidobacterium
2)patients who are judged to be ineligible by the investigator for some reason
3)HbA1c(NGSP)>=10%
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Maegawa
Organization Shiga University of Medical Science
Division name Department of Medicine
Zip code 520-2192
Address Tsukinowa, Seta, Otsu, Shiga
TEL 077-548-2222
Email maegawa@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Katsutaro
Middle name
Last name Morino
Organization Shiga University of Medical Science
Division name Department of Medicine
Zip code 520-2192
Address Tsukinowa, Seta, Otsu, Shiga
TEL 077-548-2223
Homepage URL
Email morino@belle.shiga-med.ac.jp

Sponsor
Institute Department of Medicine,
Shiga University of Medical Science
Institute
Department

Funding Source
Organization Department of Medicine,
Shiga University of Medical Science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shiga University of Medical Science
Address Tsukinowa Seta, Otsu, Shiga
Tel 077-548-3576
Email hqrec@belle.shiga-med.ac.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 滋賀医科大学(滋賀県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 07 Day

Related information
URL releasing protocol https://eiyou.or.jp/gakujutsu/20th/pdf/jsmcn_Vol20.Supplement_vo.pdf
Publication of results Partially published

Result
URL related to results and publications https://eiyou.or.jp/gakujutsu/20th/pdf/jsmcn_Vol20.Supplement_vo.pdf
Number of participants that the trial has enrolled 20
Results
Primary outcome, HbA1c showed no significant difference compared to baseline. However, plasma GLP-1 concentration was significantly increased after Bifidobacterium treatment. 
Results date posted
2019 Year 05 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gender(9 male, 6 female)
Age: 60.2 (11.6)
Body weight: 67.4 (7.8)
HbA1c: 7.5 (0.7)
Participant flow
28 patients were selected by initial screening and 20 patients were enrolled with written informed consent. A patient was diagnosed to type 1 diabetes by anti-GAD antibody and excluded. 3 patients was dropped out one patient was excluded due to liver cancer. Overall, 15 subjects were used for analysis.  
Adverse events
Two patients claimed gastrointestinal symptom include diarrhea and nausea. 
Outcome measures
HbA1c,GLP-1,GIP, Fasting blood glucose, Glycoalbumin
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2012 Year 04 Month 27 Day
Date of IRB
2012 Year 04 Month 24 Day
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2013 Year 08 Month 01 Day
Date of closure to data entry
2013 Year 08 Month 01 Day
Date trial data considered complete
2013 Year 09 Month 01 Day
Date analysis concluded
2013 Year 10 Month 01 Day

Other
Other related information 1)Background
ID,Birth date,Sex,Age,Height,Weight,Drug used to treat diabetes,Drug used concomitantly,Complications,Medical history
2)Blood test
glycoalbumin,HbA1c,FBS,Insulin,CPR index,glucagon,GLP-1,Lipidomics,T-Cho,LDL-C,HDL-C,TG
3)Bacterial flora
4)Adverse event
5)questionnaire of a bowel movement

Management information
Registered date
2012 Year 05 Month 07 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009281

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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