UMIN-CTR Clinical Trial

Basic information
Public title	Study on diabetes remission using weight management program for obesity and type 2 diabetes
Acronym	ADDRESS (Asama Dietary Diabetes Remission Study)
Scientific Title	Study on diabetes remission using weight management program for obesity and type 2 diabetes
Scientific Title:Acronym	ADDRESS (Asama Dietary Diabetes Remission Study)
Region	Japan

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

Objectives
Narrative objectives1	We will examine whether the focused weight management program for Japanese obese type 2 diabetics is effective for improvement and remission of diabetes compared to standard treatment based on current guidelines.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Weight after 6 months from start (weight loss of 10% or more from the start) (2) HbA1c (less than 6.5% HbA1c without diabetes medicine) after 6 months from start
Key secondary outcomes

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	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Weight management program group: Discontinue diabetes medicine at the start of treatment 3 months from the start: weight loss meal, low calorie diet of about 800 kcal / day 3 months to 6 months: Phased adjustment meal, approximately 400 kcal per meal 6 months to 12 months: individual long-term weight loss maintenance diet, calorie that can maintain weight loss Exercise therapy follows the Japanese Diabetes Society Guide
Interventions/Control_2	Standard treatment group: Treatment according to Japan Diabetes Association guideline and Japan Society for Study of Obesity guidline Target calorie: Total calorie intake (kcal) = ideal body weight (kg: height (m) x height (m) x 22) x 25 kcal / kg The target intake of each nutrient is carbohydrate = 50-60%, protein = 1.0-1.2 g / kg (<20%), fat = <25%
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Men and women aged over 20 years and and under 75 2) Patients from 0 to 10 years after being diagnosed with type 2 diabetes 3) Patients with HbA1c >= 6.6% with diet only during the last 12 months 4) Patients with oral diabetes drug HbA1c >= 6.2% 5) Patients with BMI> 25 kg/m2 and <45 kg/m2 6) Patients for whom consent is documented for participation in this study
Key exclusion criteria	1) Patients who are using insulin 2) Patient with recent HbA1c >= 12.1% 3) Patients with weight loss> 5 kg within the past 6 months 4) Patients with recent eGFR <30 ml/min / 1.73 m2 5) Patients with drug addiction 6) Patients with malignant tumors 7) Patients who developed myocardial infarction within the past 6 months 8) Patients with grade 3 or higher severe heart failure of the New York Heart Association (NYHA) 9) Patients with learning disabilities 10) Patients being treated with antiobesity drugs 11) Patients diagnosed with eating disorders 12) Pregnant women, lactating women and patients with the possibility of being pregnant (intention) 13) Patients who need inpatient treatment due to depression or patients with antipsychotic oral administration 14) Patients participating in other clinical studies 15) Patients judged inappropriate for judgment by doctor's judgment
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Motoji Middle name Last name Naka
Organization	Asama General Hospital
Division name	Diabetes Medicine
Zip code	3858558
Address	1862-1 Iwamurada, Saku, Nagano
TEL	0267-67-2295
Email	n-motoji@city.saku.nagano.jp

Public contact
Name of contact person	1st name Nishimori Middle name Last name Eita
Organization	Asama General Hospital
Division name	Diabetes Medicine
Zip code	3858558
Address	1862-1 Iwamurada, Saku, Nagano
TEL	0267-67-2295
Homepage URL
Email	eita-nishimori@umin.ac.jp

Sponsor
Institute	Asama General Hospital
Institute
Department

Funding Source
Organization	Asama General Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asama General Hospital
Address	1862-1 Iwamurada, Saku, Nagano, Japan
Tel	0267-67-2295
Email	asama-soumu@city.saku.nagano.jp

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

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 13 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	Enrolling by invitation
Date of protocol fixation	2018 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date	2019 Year 01 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	2018 Year 12 Month 13 Day
Last modified on	2019 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039680