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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000873
Receipt No. R000001050
Scientific Title Effects of low-carbohydrate diet on glycemic control in type 2 diabetes
Date of disclosure of the study information 2007/10/31
Last modified on 2015/02/25

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Basic information
Public title Effects of low-carbohydrate diet on glycemic control in type 2 diabetes
Acronym Effects of low-carbohydrate diet in type 2 diabetes
Scientific Title Effects of low-carbohydrate diet on glycemic control in type 2 diabetes
Scientific Title:Acronym Effects of 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 an efficacy of low-carbohydarate diet on glycemic contorol in type 2 diabetes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes serum glucose and HbA1c levels, serum lipid profiles, BMI and body weight
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 low-carbohydrate diet
Interventions/Control_2 conventional diet(high-carbohydrate diet)
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
75 years-old >
Gender Male and Female
Key inclusion criteria type 2 diabetes
Key exclusion criteria HbA1c>8.0, chronic renal failure, midication with sulfonylureas, malignancy
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Haimoto
Organization Haimoto Clinic
Division name Director
Zip code
Address 1-80 Yayoi-cho, Kasugai, 486-0838 Aichi, Japan
TEL 0568-85-0567
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Haimoto Clinic
Division name Division of Internal Medicine
Zip code
Address
TEL
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
2007 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nutritionandmetabolism.com/
Number of participants that the trial has enrolled
Results
Background 
 With respect to energy metabolism, acute metabolic responses to high-carbohydrate meals (HCMs) have not been determined in LCD patients with T2DM. 
Subjects and methods
We enrolled 31 subjects with T2DM (mean age: 62 yrs, mean hemoglobin A1c level: 6.9%), of whom 13 were on a strict LCD (26% carbohydrate diet), and 18 a moderate one (44% carbohydrate diet). Two isocaloric meals were administered to all subjects in a randomized crossover design. The carbohydrate:protein:fat ratios of HCMs and low-carbohydrate meals (LCMs) were 59:20:21 and 7:20:73, respectively. Serum beta-hydroxybutyrate, acetoacetate, free fatty acids (FFAs), triglyceride and insulin, and plasma glucose concentrations were measured for 120 minutes after the intake of each meal.
Results
HCMs rapidly decreased postprandial beta-hydroxybutyrate, acetoacetate and FFA concentrations within 2 hours in all patients in combination with rapid increases in serum insulin and plasma glucose, while LCMs increased or did not change beta-hydroxybutyrate, acetoacetate and FFAs (P<0.001 for all). HCMs did not change postprandial triglyceride concentrations over 2 hours, while LCMs gradually increased them (P<0.001). 
HCMs sharply and rapidly decreased postprandial beta-hydroxybutyrate and acetoacetate concentrations in strict LCD subjects over 2 hours, but only slightly decreased them in moderate LCD subjects (P<0.001, difference between strict and moderate LCD subjects). The parameter deltaketone bodies (level at 120 minutes - level at baseline) was significantly correlated with the insulinogenic index (r=0.503 for Beta-hydroxybutyrate and 0.509 for acetoacetate), but not with total insulin secretory capacity. Moreover, HCMs slightly decreased postprandial triglyceride levels in strict LCD subjects but somewhat increased them in the moderate LCD subjects (P=0.002). The parameter deltatriglyceride was significantly correlated with background dietary %carbohydrate (r=0.484).
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
2007 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2008 Year 09 Month 30 Day
Date of closure to data entry
2008 Year 12 Month 31 Day
Date trial data considered complete
2009 Year 01 Month 31 Day
Date analysis concluded
2009 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2007 Year 10 Month 31 Day
Last modified on
2015 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001050

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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