UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010407 |
|---|---|
| Receipt number | R000012166 |
| Scientific Title | An open label, randomized controlled trial of low carbohydrate diet for the comparison of pliotropic effects between breakfast and dinner |
| Date of disclosure of the study information | 2013/04/03 |
| Last modified on | 2017/04/24 16:55:30 |
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Basic information
Public title
An open label, randomized controlled trial of low carbohydrate diet for the comparison of pliotropic effects between breakfast and dinner
Acronym
An open label, randomized controlled trial of low carbohydrate diet for the comparison of pliotropic effects between breakfast and dinner
Scientific Title
An open label, randomized controlled trial of low carbohydrate diet for the comparison of pliotropic effects between breakfast and dinner
Scientific Title:Acronym
An open label, randomized controlled trial of low carbohydrate diet for the comparison of pliotropic effects between breakfast and dinner
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To compare the pleiotropic effect including blood glucose fluctuation on patients with type 2 diabetes between low carbohydrate diet only breakfast and only dinner.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose fluctuation(AUC,M values,MAGE)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
10% carbohydrate diet only breakfast for two days
Interventions/Control_2
10% carbohydrate diet only dinner for two days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes
2. Patients who are admitted to the purpose of glycemic control more than one week
Key exclusion criteria
1.Mediacal history and/or complication of diabetic ketoasidosis.
2.Mediacal history and/or complication of diabetic hypoglycemia.
3.Severe infection, before and after surgery or severe trauma.
4.Treatment with glucocorticoid.
5.Uncontrolled hypertension(systric blood pressure>160 mmHg or diastolic blood pressure >100 mmHg)
6.Proliferative retinopathy or maculopathy.
7.History of maligmancy.
8.Severe health problems not suitable for the study.
9.Women with possibility of pregnancy, or during pregnancy and lactation.
10.Cases that physicians deem inappropriate as the target of the test.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinari TAKAMURA |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Disease control and homeostasis
Zip code
Address
13-1 Takara-machi,kanazawa,Ishikawa,Japan
TEL
076-265-2234
ttakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinari Takamura |
Organization
Kanazawa University Graduate School of Medical Sciences
Division name
Department of Disease control and homeostasis
Zip code
Address
13-1 Takara-machi,kanazawa,Ishikawa,Japan
TEL
076-265-2234
Homepage URL
ttakamura@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Graduate School of Medical Sciences
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
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
| 2013 | Year | 04 | Month | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 04 | 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
| 2013 | Year | 04 | Month | 03 | Day |
Last modified on
| 2017 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012166
