UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003809 |
|---|---|
| Receipt number | R000004600 |
| Scientific Title | Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2013/01/06 09:59:10 |
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Basic information
Public title
Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes
Acronym
Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes
Scientific Title
Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes
Scientific Title:Acronym
Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetic patient
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of low-fat, high- fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of glucose, lipid profile, and endothelial function after diet intervention.
Key secondary outcomes
Change of oxidative stress and periodontitis marker after diet intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low-fat, high-fiber diet intervention period of 2month
Interventions/Control_2
control period of 2month
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
HbA1c level of 6.0 % or more and below 10.0 %
Key exclusion criteria
(1)Patient with severe vascular disease
(2)Patient with severe hepatic or renal disease
(3)Patients with cancer disease
(4)Patients with infectious disease
(5)taking alpha-GI
(6)Previous use of warfarin within 1 month
(7)insulin treatment
(8)Patient who change drug treatment within the 2-month period
(9)Patient with rapid weight loss
(10)Patient who enrolled in another study within 1 month
(11)vegetable allergy, vegetarian
(12)Pregnancy and breast-feeding patient
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Nishio |
Organization
Department of Medicine, Shiga University of Medical Science
Division name
Department of Medicine
Zip code
Address
Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL
077-548-2223
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Kondo |
Organization
Department of Medicine, Shiga University of Medical Science
Division name
Department of Medicine
Zip code
Address
Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL
077-548-2223
Homepage URL
kon@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
| 2010 | Year | 07 | Month | 01 | 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
| 2008 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | 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
| 2010 | Year | 06 | Month | 23 | Day |
Last modified on
| 2013 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004600
