UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000873 |
|---|---|
| Receipt number | 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 20:03:21 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001050
