UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009866
Receipt number 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 16:13:14

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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 or person

Institute

Haimoto Clinic

Institute

Department

Personal name



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

Value
https://center6.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