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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027721
Receipt No. R000031759
Scientific Title Effects of dietary counselling for individuals with pre-diabetes: Comparison of dietary instructions focusing "meal-sequence" or "nutritional balance" with conventional approach
Date of disclosure of the study information 2017/06/12
Last modified on 2018/06/27

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Basic information
Public title Effects of dietary counselling for individuals with pre-diabetes: Comparison of dietary instructions focusing "meal-sequence" or "nutritional balance" with conventional approach
Acronym Dietary counseling for PPG management in pre-diabetes
Scientific Title Effects of dietary counselling for individuals with pre-diabetes: Comparison of dietary instructions focusing "meal-sequence" or "nutritional balance" with conventional approach
Scientific Title:Acronym Dietary counseling for PPG management in pre-diabetes
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate efficacy of dietary counselling focused on "meal-sequence" or "nutritional balance" in comparison to conventional approach in individuals with pre-diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c, GA, 1,5-AG, fasting glucose levels
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Dietary counseling focusing on "meal sequence"
Interventions/Control_2 Dietary counseling focusing on "nutritional balance"
Interventions/Control_3 Conventional dietary counseling approach
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
40 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1. Individuals who have Kansai Electric Power Health Insurance; and work in designated office belonging to Kansai Electric Power Company
2. Individuals who require active support based on results of medical health check-up
3. Fasting plasma glucose levels <126 mg/dL
4. HbA1c at screening: 5.6% or higher
5. BMI at screening: 18-30 kg/m2
6. Age at screening: 40-60 years old
7. Gender: Male and females
Key exclusion criteria 1. Individuals receiving anti-diabetic drugs
2. Individuals with renal impairment
3. Individuals with hepatic impairment
4. Individuals with history of cerebrovascular disorders and/or ischemic heart diseases
5. Individuals with heart failure (NYHA I-IV)
6. Individuals with history of GI surgery
7. Individuals with excess alcohol consumption
8. Individuals with low Hb values: male, < 13.0g/dL and female 12.5 g/dL
9. Individuals who cannot follow orders from chief investigator or sub investigator
10. Individuals enrolled in other clinical trials
11. Pregnant individuals or those suspected of pregnancy
12. Individuals who are judged as inappropriate to be enrolled in this trials by chief investigator or sub investigators
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Seino
Organization Kansai Electric Power Medical Research Institute
Division name Yutaka Seino Distinguished Center for Diabetes Center
Zip code
Address 1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL 078-303-6090
Email seino.yutaka@e2.kepco.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Yabe
Organization Kansai Electric Power Medical Research Institute
Division name Yutaka Seino Distinguished Center for Diabetes Center
Zip code
Address 1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL 078-303-6090
Homepage URL
Email ydaisuke-kyoto@umin.ac.jp

Sponsor
Institute Kansai Electric Power Medical Research Institute
Institute
Department

Funding Source
Organization Kansai Electric Power Medical Research Institute; and Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 関西電力株式会社・本店(大阪市)
株式会社関電エネルギーソリューション・本社(大阪市)
関電プラント株式会社・本店(大阪市)
株式会社環境総合テクノス・本店(大阪市)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 12 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
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 Main results already published
Date of protocol fixation
2017 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 25 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
2017 Year 06 Month 12 Day
Last modified on
2018 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031759

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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