UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000010780