UMIN-CTR Clinical Trial

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

type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology

Institute

Department

Personal name

Organization

TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人TDE　糖尿病・内分泌内科クリニックTOSAKI (愛知県)

Date of disclosure of the study information

2016

Year

04

Month

29

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2016

Year

04

Month

29

Day

Last modified on

2020

Year

03

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025431