UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021952 |
|---|---|
| Receipt number | R000025308 |
| Scientific Title | Study about the effect of minutes and the number of times of dietary intervention to QOL and dietary compliance. |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2017/09/05 00:02:12 |
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Basic information
Public title
Study about the effect of minutes and the number of times of dietary intervention to QOL and dietary compliance.
Acronym
Effevtive minutes and the number of times of dietary intervention
Scientific Title
Study about the effect of minutes and the number of times of dietary intervention to QOL and dietary compliance.
Scientific Title:Acronym
Effevtive minutes and the number of times of dietary intervention
Region
| Japan |
Condition
Condition
Impaired glucose tolerance or Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate how long time and how many times we spend on dietary intervention are effective.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Diabetes Therapy-Related QOL (DTR-QOL), compliance of diet therapy, frequency of reducing or increasing of antidiabetic drugs, rate of trial interruption.
Key secondary outcomes
Glycoalbumin, HbA1c(NGSP), body weight, blood pressure, urine albumin creatinine ratio (mg/Cr), serum LDL-C, HDL-C, TG, ALT, eGFR.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In only this group, dietary instruction for 30 minutes at the start, each 20 minute at the 1th and 5th month.
Dietitians do dietary instruction with same materials in both groups, and the total time of instruction is 70 minutes each patient.
In both groups,Daily total energy intake is calculated by multiplying their standard weight by 30 (kcal/kg). Standard macronutrient energy ratio is divided as follows: carbohydrates is 50 % (more than 150 g/day), protein is less than 20 %, and the rest percent is from fats.
And at the start of the study and at the 12th month, we conduct a questionnaire about Diabetes Therapy Related-QOL (DTR-QOL) by iPad or a paper. At the same time, we conduct Food Frequency Questionnaire (FFQ) based on a food diary that patients keep. Then we evaluate compliance of diet therapy.
In both groups, we do not change medication for diabetes in principle, during study. But to prevent hypoglycemia, we reduce a dose in the case that the doctor judge. We recommend patients to increase a dose of antidiabetic drugs if their HbA1c (NGSP) have been greater than 8.0 % for more than 3 months or 7.0 % for more than 6 months. And patients agree to increase a dose of antidiabetic drugs, we will.
Every month during this study, we monitor body weight, BMI, systolic blood pressure, diastolic blood pressure, HbA1c, glycoalbumin. At the 3th, 6th, 9th, 12th month, we monitor serum AST, ALT, gamma-GTP, blood urea nitrogen, Cr, UA, LDL-C, HDL-C, TG, eGFR, urine albumin creatinine ratio (mg/gCr).
Interventions/Control_2
Dietary instruction for 30 minutes at the start, each 5 minute at the 1th, 2th, 3th, 4th, 5th, 6th, 7th, 8th month.
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
Out-patients with impaired glucose tolerance or Type 2 diabetes mellitus, who have been not treated with dietary instruction by diaetitian for past more than 12 months. In addition, patients who have not had any changes of medication for diabetes, hypertension and dyslipidemia for past more than 3 months.
Key exclusion criteria
1. Type 1 diabetic patients
2. Patients who has renal dysfunction (eGFR is less than 30mL/min/1.73m2)
3. Pregnant women
4. Patients judged by the doctor to be ineligible
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Tosaki |
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name
Diabetes and Endocrinology
Zip code
Address
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL
052-800-2333
nrd49075@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tosaki |
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name
Diabetes and Endocrinology
Zip code
Address
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL
052-800-2333
Homepage URL
nrd49075@nifty.com
Sponsor or person
Institute
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
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
医療法人TDE 糖尿病・内分泌内科クリニックTOSAKI (愛知県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 18 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2016 | Year | 04 | Month | 17 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025308
