UMIN-CTR Clinical Trial

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

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

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

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

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

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

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

Institute

Asama General Hospital

Institute

Department

Personal name

Organization

Asama General Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Asama General Hospital

Address

1862-1 Iwamurada, Saku, Nagano, Japan

Tel

0267-67-2295

Email

asama-soumu@city.saku.nagano.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

12

Month

13

Day

Last modified on

2019

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039680