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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009866
Receipt No. R000010780
Scientific Title Associations of changes in HbA1c, insulin sensitivity, abdominal fat and plasma fatty acid composition with changes in macronutrients, carbohydrate sources and alcohol intake under a 6-month moderate low-carbohydrate diet in type 2 diabetes
Date of disclosure of the study information 2013/01/25
Last modified on 2019/09/25

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Basic information
Public title Associations of changes in HbA1c, insulin sensitivity, abdominal fat and plasma fatty acid composition with changes in macronutrients, carbohdyrate sources and alcohol intake under a 6-month moderate low-carbohydrate diet in type 2 diabetes
Acronym Associations of changes in HbA1c, insulin sensitivity and abdominal fat with changes in macronutrients, carbohydrate sources and alcohol intake under a moderate low-carbohydrate diet in type 2 diabetes
Scientific Title Associations of changes in HbA1c, insulin sensitivity, abdominal fat and plasma fatty acid composition with changes in macronutrients, carbohydrate sources and alcohol intake under a 6-month moderate low-carbohydrate diet in type 2 diabetes
Scientific Title:Acronym Associations of changes in HbA1c, insulin sensitivity and abdominal fat with changes in macronutrients, carbohydrate sources and alcohol intake under a moderate low-carbohydrate diet in type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 To clarify associations of changes in macronutrients, carbohydrate sources and alcohol intake with changes in Hb1c, insulin sensitivity, abdominal fat and plasma fatty acid composition under a 6-month moderate low-carbohydrate diet in type 2 diabetes.
Basic objectives2 Others
Basic objectives -Others We also survey the changes in BMI, HbA1c levels, serum lipid profiles and changes in types of protein and fat, micronutrients estimated by 3-day dietary records over 6 months.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes BMI, Hemoglobin A1c levels, plasma fatty composition, insulin sensitivity estimated by 75g-glucose tolerance test, abdominal fat measured by CT, macronutrients, carbohydrate sources, the type of protein, fat and alcohol by 3-day dietary records at baseline and after 6 months.
Key secondary outcomes Blood pressure, serum lipid profiles, blood chemical examinations, CT values of liver and spleen, micronutrients and salt equivalents estimated by 3-day dietary records, doses of anti-diabetic drugs, lipid lowering drugs and anti-hypertensive drugs at baseline and after 6 months.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 A moderate-low carbohydrate diet(dietary %energy from carbohydrate ranged from 30 to 60%)
Interventions/Control_2
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes not taking anti-diabetic patients
Key exclusion criteria Patients with serum creatinine levels > 2.0 mg/dl, ketoacidosis, soft drink ketosis, severe heart failure, severe liver cirrhosis, cancer, insulin therapy and implementing a low-carbohydrate diet at baseline.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Haimoto
Organization Haimoto Clinic
Division name Department of Internal Medicine
Zip code
Address 1-80 Yayoi, Kasugai-city, 486-0838 Aichi, Japan
TEL 0568-85-0567
Email haimoto@gol.com

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Haimoto
Organization Haimoto Clinic
Division name Department of Internal Medicine
Zip code
Address 1-80 Yayoi, Kasugai-city, 486-0838 Aichi, Japan
TEL 0568-85-0567
Homepage URL
Email haimoto@gol.com

Sponsor
Institute Haimoto Clinic
Institute
Department

Funding Source
Organization Haimoto Clinic
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 01 Month 25 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 Completed
Date of protocol fixation
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 04 Day
Last follow-up date
2018 Year 03 Month 30 Day
Date of closure to data entry
2018 Year 10 Month 30 Day
Date trial data considered complete
2018 Year 11 Month 30 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 24 Day
Last modified on
2019 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010780

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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