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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028132
Receipt No. R000032191
Scientific Title ASAHI RIZAP Low-carbohydrate diet Study
Date of disclosure of the study information 2017/07/07
Last modified on 2017/07/07

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Basic information
Public title ASAHI RIZAP Low-carbohydrate diet Study
Acronym ASAHI RIZAP STUDY
Scientific Title ASAHI RIZAP Low-carbohydrate diet Study
Scientific Title:Acronym ASAHI RIZAP STUDY
Region
Japan

Condition
Condition Type2 Diabetes mellitus
Dyslipidemia
Hypertension
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the influence of low-carbohydrate(LCD 50g or 120g) diet for patients with diabetes,dyslipidemia and hypertension.
Basic objectives2 Others
Basic objectives -Others To evaluate the differences between LCD 50g and LCD 120g.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Every month after intervention,body weight,blood pressure,body composition will be assessed.
2,3 month after intervention,HbA1c,FPG,serum keton body,kidney and liver function and lipid profile will be checked.
C-peptide,urinary albumin,PWV/ABI will be checked at last visit.

Key secondary outcomes To evaluate the differences between LCD 50g and LCD 120g by assessing parameters.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 [Low-carbohydrate(LCD50g)group]
Total calorie is designed according to ideal BMI and indivisual activity,and kept until study ends.

0-8w(LCD 50g period):Carbohydrate is restricted and participants are provided food contains 50g of carbohydrates per day.

8-12w(LCD 120g period):Carbohydrate is still restricted, every meal is participants'choice(no food offer),keeping 120g of carbohydrates per day.

well trained dietitians check food content everyday.



Interventions/Control_2 [Low-carbohydrate(LCD120g)group]

Total calorie is designed according to ideal BMI and indivisual activity,and kept until study ends.

0-8w(LCD 120g period):Carbohydrate is restricted and participants are provided food contains 120g of carbohydrates per day.

8-12w(LCD 120g period):Carbohydrate is still restricted, every meal is participants' choice(no food offer),keeping 120g of carbohydrates per day.

well trained dietitians check food content everyday.





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
65 years-old >
Gender Male and Female
Key inclusion criteria a)25<=BMI<35
b)Patients with Type2 diabetes,dyslipidemia,or hypertension.
c)HbA1c<=8.5%
d)Patients receiving certain diet and exercise therapy continuously from at least 4 weeks prior to the start of intervention.
e)Patients not taking medications in period from at least 4 weeks prior to the start of intervention,or taking same-dose medications continuously from at least 4 weeks prior to the start of intervention.
f)Patients who have been explained details of the study,understood them,and given written informed consent for participation.
Key exclusion criteria a)Patients taking SGLT2 inhibitor
b)Patients who have severe food allergy
c)Pregnant woman,breast-feeding women and expectants.
d)Patients with diabetic nephropathy of stage3,4,5.
e)Patients with serious hepatic dysfunction.
f)Patients with serious hepatic diseases such as hepatitis.
g)sBP>=150mmHg or dBP>=100mmHg
h)Patients with history of cerebral or cardiovascular events such as cerebral infarction or miocardial infarction or severe congestive heart failure within 90 days prior to the start of intervention.
i)Patients with unstable diabetic retinopathy.
j)Patients with malignant tumors (those who are currently receiving no treatment and had no recurrense, and those considered unlikely to have any recurrense during the study period are eligible for the study)
k)Patients with severe mental disorders.
l)Patients deemed unsuitable for participation in the study by the investigator due to other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAKAKO KIKUCHI
Organization The Institute for Adult Diseases,Asahi Life Foundation
Division name chief director
Zip code
Address Sunaga Bldg.2-2-6 Nihonbashi Bakurocho,Chuo-ku,Tokyo
TEL 03-3639-5501
Email kikuchi-tk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name CHIEKO KASHIWADO
Organization Rizap
Division name Medical Division
Zip code
Address Shinjuku Front Tower 31F,2-21-1 Kitashinjuku,Shinjuk-ku,Tokyo
TEL 03-5389-8070
Homepage URL
Email chieko.kashiwado@rizapgroup.com

Sponsor
Institute The Institute for Adult Diseases,Asahi Life Foundation
Institute
Department

Funding Source
Organization Rizap
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 07 Month 07 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
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 10 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
2017 Year 07 Month 07 Day
Last modified on
2017 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032191

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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