UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of mini-low carbohydrate diet on glucose metabolism in patients with type 2 diabetes: open-label randomized controlled study
Title of the study (Brief title)	Effect of mini-low carbohydrate diet on glucose metabolism in patients with type 2 diabetes (EMILY Study)
Region	Japan

Condition
Condition	Type2diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effectiveness of diet therapy that reduce carbohydrate at dinner and diet therapy with calorie counting with a food exchange list mainly focusing on energy restriction in type 2 diabetes treated with medication or diet therapy only.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in HbA1c
Key secondary outcomes	1. Change in fasting plasma glucose,1,5-Anhydroglucitol,glycated albumin,fasting plasma insulin 2. Change in body weight,waist circumference,body composition and basal energy expenditure. 3. Change in Lipid profile(LDL-C,HDL-C,TG) 4. Level of performance of dietary management(intake energy and nutrition survey) 5. Level of satisfaction with therapy,quality of life(questionary survey)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Moderate diet group A nationally registered dietitian guides a calorie-restricted diet of 25-30kcal/IBW day using a food exchange list.Periodic guidance is repeated during the 3months study period.
Interventions/Control_2	Mini low carbohydrate diet group A nationally registered dietitian guides a diet 25-30kcal/IBW/day for breakfast and lunch.Only carbohydrate is restricted at dinner within same calorie. Periodic guidance is repeated during the 3months study period.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with type 2 diabetes. 2. Age more than 20 3. Under treatment with no antidiabetic agents, or with oral hypoglycemic drugs. 4. Patients with Hb1c less than 8.5% at entry.
Key exclusion criteria	1. Complication by stage 3A or more severe diabetic nephropathy, or stage 3 or more severe chronic kidney disease(CKD)not associated with diabetes. 2. Malignant or acute disease 3. Severe liver disease 4. Decreased pancreatic function due to chronic pancreatitis 5. Hyperthyroidism 6. Adrenal insufficiency 7. Under steroid treatment 8. Patients judged to have difficulty in performing diabetics on his/her own due to dementia etc. 9. Other patients judged unsuitable by the attending physician.
Target sample size	50

Research contact person
Name of lead principal investigator	Yasuo Terauchi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Address	3-9 Fukuura,Kanazawa-ku,Yokohama
TEL	045-787-2800
Email	terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person	Masayo Kimura
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Address	3-9 Fukuura,Kanazawa-ku, Yokohama
TEL	045-787-2800
Homepage URL
Email	masayo59@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine Department of Endocrinology and Metabolism
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor
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	横浜市立大学附属病院　　　　　　　　　Yokohama City University 中島内科クリニック Nakajima Naika Clinic

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 10 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date	2014 Year 10 Month 01 Day
Date of closure to data entry	2014 Year 10 Month 01 Day
Date trial data considered complete	2014 Year 10 Month 01 Day
Date analysis concluded	2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 18 Day
Last modified on	2016 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015037