UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043955 |
|---|---|
| Receipt number | R000050204 |
| Scientific Title | Effects of nutritional intervention on the clinical, physical and nutritional parameters associated with the development and progression of type 2 diabetic nephropathy: a randomized, controlled trial |
| Date of disclosure of the study information | 2021/04/17 |
| Last modified on | 2022/08/13 15:33:58 |
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Basic information
Public title
Effects of nutritional intervention on the clinical parameters associated with diabetic nephropathy in patients with type 2 diabetes mellitus: a randomized, controlled trial
Acronym
Succeed trial
Scientific Title
Effects of nutritional intervention on the clinical, physical and nutritional parameters associated with the development and progression of type 2 diabetic nephropathy: a randomized, controlled trial
Scientific Title:Acronym
Succeed trial
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether frequent nutritional education by a dietitian could improve prognostic parameters associated with the development and progression of diabetic nephropathy and clarify which clinical parameters were associated with the nutritional states by a randomized controlled trial in patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in clinical, physical and nutritional factors over time between the intensive intervention and control groups during the first two years of the study, and association of improved or worsening nutritional and clinical factors.
Key secondary outcomes
Achievement of treatment goals for levels of control of weight, blood pressure, blood glucose, and serum lipids
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
An intensive intervention group that received nutritional education at every outpatient visit
Interventions/Control_2
An usual intervention group that received nutritional education only once a year
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes mellitus and DKD caused by type 2 diabetes (CKD stage G1-3) aged 20 years or older who attended the Division of Endocrinology and Metabolism and the Division of Nephrology at Jichi Medical University Hospital between May 2013 and October 2016 and had not received nutritional education in the past 5 years were included in the study.
Key exclusion criteria
Patients who have received individual nutritional guidance by a registered dietitian at our hospital in the past.
Minors and those who have difficulty in obtaining informed consent from the patient
Patients with stage G4 or G5 chronic kidney disease
Patients with extremely poor blood glucose control with HbA1c of 10% or higher
Patients with nephrotic syndrome
Patients with type 1 diabetes mellitus
Patients with hereditary and secondary diabetes mellitus
Patients with primary and secondary glomerular diseases other than diabetes mellitus
Patients with secondary hypertension
Patients with unstable angina pectoris, myocardial infarction or stroke within 6 months prior to the start of the study
Patients with malignancy or life-threatening diseases that may cause death within 2 years
Patients with hepatic dysfunction (AST or ALT of 100 mU/ml or higher, or obvious liver cirrhosis)
Patients who are pregnant or intend to become pregnant during the study period.
Other patients who are judged by the attending physician to be inappropriate for the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Kawabata |
Organization
Jichi Medical University Hospital
Division name
Department of Clinical Nutrition
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke Tochigi, Japan
TEL
+81-0285-58-7574
nkawabata@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Kawabata |
Organization
Jichi Medical University Hospital
Division name
Department of Clinical Nutrition
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke Tochigi, Japan
TEL
+81285587574
Homepage URL
nkawabata@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Lapan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JIchi Medical University
Address
3311-1 Yakushiji, Shimotsuke Tochigi, Japan
Tel
+81-0285-58-8960
rinri@jichi.ac.jp
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
| 2021 | Year | 04 | Month | 17 | 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
96
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
| 2012 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 17 | Day |
Last modified on
| 2022 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050204
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/08/13 | 臨床研究計画書umin.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/08/13 | J of Diabetes Invest - 2021 - Kawabata - Comparison of the effects of frequent versus conventional nutritional.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/08/13 | J of Diabetes Invest - 2021 - Kawabata - Comparison of the effects of frequent versus conventional nutritional.pdf |
