UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031010 |
|---|---|
| Receipt number | R000035403 |
| Scientific Title | The efficacy of low carbohydrate bread on postprandial hyperglycemia in type 2 diabetes patients |
| Date of disclosure of the study information | 2018/01/26 |
| Last modified on | 2019/08/31 10:10:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy of low carbohydrate bread on postprandial hyperglycemia in type 2 diabetes patients
Acronym
Low-carbohydrate bread and postprandial hyperglycemia
Scientific Title
The efficacy of low carbohydrate bread on postprandial hyperglycemia in type 2 diabetes patients
Scientific Title:Acronym
Low-carbohydrate bread and postprandial hyperglycemia
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy of low carbohydrate bread on postprandial hyperglycemia in type 2 diabetes patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Peak blood glucose level after breakfast
Key secondary outcomes
The increase of blood glucose level and AUCduring 2hours after meal
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low-carbohydrate bread (mean 0.22 g/g) 2 days
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
Inpatients with type 2 diabetes whose blood glucose levels are stable during the study
Key exclusion criteria
!. Allergy to the bread
2. Unstable appetite
3.Gastrointestinal disease
4.Diseases which directly affect blood glucose levels
5. The patients whom the doctors defines as not suitable to the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health University
Division name
Department of Endocrinology and Metabolism, Department of Internal Medicine, School of Mediicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562939242
aslapin@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Healtu University, School of Medicine
Division name
Division of Endocrinology and Metabolism, Department of Internal Medicine, School of Mediicine
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562939242
Homepage URL
aslapin@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Department of Internal Medicine, Fujita health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Research Promotion and Support
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562932111
kenshien@fujita-hu.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
藤田医科大学医学部 内分泌・代謝内科学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
35
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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 26 | Day |
Last modified on
| 2019 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035403
