UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027721 |
|---|---|
| Receipt number | 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 01:21:24 |
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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
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
ydaisuke-kyoto@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Medical Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031759
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