UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007899 |
|---|---|
| Receipt number | 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 20:37:28 |
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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
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
morino@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Medicine,
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009281
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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