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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035237
Receipt No. R000039680
Scientific Title Study on diabetes remission using weight management program for obesity and type 2 diabetes
Date of disclosure of the study information 2018/12/13
Last modified on 2018/12/13

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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
Middle name
Last name Motoji Naka
Organization Asama General Hospital
Division name Diabetes Medicine
Zip code
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
Middle name
Last name Eita Nishimori
Organization Asama General Hospital
Division name Diabetes Medicine
Zip code
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
Address
Tel
Email

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
2018 Year 12 Month 13 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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