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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024266
Receipt No. R000027941
Scientific Title Effectiveness of low carbohydrate diet for basal insulin titration in Type 1 Diabetes.
Date of disclosure of the study information 2016/10/05
Last modified on 2016/10/03

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Basic information
Public title Effectiveness of low carbohydrate diet for basal insulin titration in Type 1 Diabetes.
Acronym Low carbohydrate diet for basal insulin titration in Type 1 Diabetes.
Scientific Title Effectiveness of low carbohydrate diet for basal insulin titration in Type 1 Diabetes.
Scientific Title:Acronym Low carbohydrate diet for basal insulin titration in Type 1 Diabetes.
Region
Japan

Condition
Condition Type 1 diabetes.
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of low carbohydrate diet for basal insulin titration in type 1 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes mean plasma glucose level, M value, MAGE
Key secondary outcomes Incidence of hypoglycemia and hyperglycemia

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Low carbohydrate diet
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
15 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with type 1 diabetes in our institution
Key exclusion criteria 1)Uncotroled hypertention(BPs>200mmHg/BPs>120mmHg(
2)serum Cre>2.0mg/dL(male), >1.5mg/dL(female)
3)Pregnant
4)Ketosis
5)HbA1c>12%
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takamura Toshinari
Organization Kanazawa University Hospital
Division name Endocrinology and Metabolism 1
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2233
Email ttakamura@m-kanazawa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamura Toshinari
Organization Kanazawa University Hospital
Division name Endocrinology and Metabolism 1
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2233
Homepage URL
Email ttakamura@m-kanazawa.jp

Sponsor
Institute Kanazawa University Hospital
Endocrinology and Metabolism 1
13-1 Takara-machi, Kanazawa, Ishikawa
Institute
Department

Funding Source
Organization none
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
Email

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
2016 Year 10 Month 05 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
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 03 Day
Last modified on
2016 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027941

Research Plan
Registered date File name
2017/10/06 160107期間延長最終計画書.doc

Research case data specifications
Registered date File name
2017/10/06 160107期間延長最終.doc

Research case data
Registered date File name
2017/10/06 data171006.xls


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