UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study about the effect of minutes and the number of times of dietary intervention to QOL and dietary compliance.
Title of the study (Brief title)	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	Takahiro Tosaki
Organization	TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name	Diabetes and Endocrinology
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	Takahiro Tosaki
Organization	TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name	Diabetes and Endocrinology
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	Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
Name of secondary funｄer(s)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 04 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025308