UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022132
Receipt No. R000025431
Scientific Title Study about effects of macronutrient distribution to glucose control and treatment satisfaction in type 2 diabetes
Date of disclosure of the study information 2016/04/29
Last modified on 2020/03/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study about effects of macronutrient distribution to glucose control and treatment satisfaction in type 2 diabetes
Acronym Effects of macronutrient distribution to glucose control and DTSQ
Scientific Title Study about effects of macronutrient distribution to glucose control and treatment satisfaction in type 2 diabetes
Scientific Title:Acronym Effects of macronutrient distribution to glucose control and DTSQ
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Nowadays, Japan Diabetes Society states that standard macronutrient energy ratio in diabetes is generally divided as follows: carbohydrate is 50 to 60 % (more than 150 g/day), protein is less than 20 %, and the rest percent is from fat. Some patients want to be treated with a diet therapy with carbohydrate ratio less than 50 %, however, there is not enough scientific evidence about appropriate carbohydrate intakes in Japan. In this study, we conduct diet therapy with carbohydrate ratio 60 %, 50 %, 40 %, and we investigate usefulness and safety in each of them.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c (NGSP), body weight, study interruption ratio, compliance of diet therapy, the total score of the DTSQ first factor (Question no.1,4,5,6,7,8), the score of question no.2 and 3, frequency of reducing, adding, or increasing of antidiabetic drugs.
Key secondary outcomes Blood pressure, eGFR, urine albumin creatinine ratio (UACR), serum LDL-C, HDL-C, triglyceride, estimated visceral fat area, development of diabetic retinopathy, death from cardiovascular causes, the rate of myocardial infarction, the rate of stroke, rate of cancer, death from any causes.

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 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 We instruct the total daily macronutrient intake and distribution.

In only this group, macronutrient distribution: carbohydrate 60 %, protein 17 %, fat 23 %.

In all groups, daily total intake of calories is calculated by multiplying their standard weight by 30 (kcal/kg).
Dietitians do dietary instruction at the start, 1st, 2nd, 4th month. After that, we do dietary instruction every 4 months up to 60 months. We conduct 30 minute dietary instruction at the start, and the following instruction is for 20 minutes each. We have the patients to bring a 3-days food diary on each dietary instruction after starting study.
During study, we do not change medication for diabetes in principle. But to prevent hypoglycemia, we reduce a dose in the case that the doctor estimate. 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.
At the start and each diet therapy, we conduct Food Frequency Questionnaire (FFQ) based on a food diary that patients keep. Then we evaluate compliance of diet therapy.
We also conduct Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the start and after 12 months.
At the start and every 1 month after that, we monitor HbA1c, body weight, BMI, systolic blood pressure, diastolic blood pressure.
At the start and every 3 month after that, we also monitor serum ASL, ALT, gamma-GTP, blood urea nitrogen, creatinin, uric acid, LDL-C, HDL-C, triglyceride, eGFR, urine albumin creatinine ratio (mg/gCr).
Interventions/Control_2 Macronutrient distribution: carbohydrate 50 %, protein 20 %, fat 30 %.
Interventions/Control_3 Macronutrient distribution: carbohydrate 40 %, protein 21 %, fat 39 %.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Diabetic out-patients whose HbA1c is greater than 5.8 % (NGSP)
15 years-old<= , 80 years-old>
Key exclusion criteria 1. Type 1 diabetic patients
2. Patients whose urinary albumin creatinine ratio (U-ACR) has been greater than 300 mg/gCr
3. Patients has renal dysfunction (eGFR is less than 30 mL/min/1.73m2)
4. Pregnant women
5. Patients estimated by the doctor to be ineligible
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Tosaki
Organization TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name Diabetes and Endocrinology
Zip code 4680009
Address 2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL 052-800-2333
Email nrd49075@nifty.com

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Tosaki
Organization TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name Diabetes and Endocrinology
Zip code 4680009
Address 2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL 052-800-2333
Homepage URL
Email nrd49075@nifty.com

Sponsor
Institute TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethic comittee of TDE Healthcare Corporation
Address 2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
Tel 0528002333
Email nrd49075@nifty.com

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 29 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 05 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
2016 Year 04 Month 29 Day
Last modified on
2020 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025431

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.