UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000877 |
|---|---|
| Receipt number | R000001054 |
| Scientific Title | Short-term Effects of a low-carbohydrate diet on glycemic control in type 2 diabetes |
| Date of disclosure of the study information | 2007/11/02 |
| Last modified on | 2015/02/25 20:07:56 |
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Basic information
Public title
Short-term Effects of a low-carbohydrate diet on glycemic control in type 2 diabetes
Acronym
Short-term Effects of a low-carbohydrate diet in type 2 diabetes
Scientific Title
Short-term Effects of a low-carbohydrate diet on glycemic control in type 2 diabetes
Scientific Title:Acronym
Short-term Effects of a 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 a low-carbohydrate diet on type 2 diebetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose and HbA1c levels, insulin secretion, BMI, body weight, visceral fat, subcutaneous fat, abdominal circumference, antidiabetic drugs
Key secondary outcomes
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 low-carbohydrate diet
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
type 2 diabetes, HbA1c>6.5%,
Key exclusion criteria
a serum creatinine level of >2.0 mg/dl, diabetic neuropathy with symptom, proliferateve diabetic retinopathy,
malignant tumours
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Haimoto |
Organization
Haimoto Clinic
Division name
Internal Medicine
Zip code
Address
1-80 Yayoi-cho, Kasugai, 486-0838 Aichi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Haimoto Clinic
Division name
Internal Medicine
Zip code
Address
TEL
Homepage URL
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 | 11 | Month | 02 | 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
We previously demonstrated that a loosely restricted 45%-carbohydrate diet led to greater reduction in hemoglobin A1c (HbA1c) compared to high-carbohydrate diets in outpatients with mild type 2 diabetes (mean HbA1c level: 7.4%) over 2 years. To determine whether good glycemic control can be achieved with a 30%-carbohydrate diet in severe type 2 diabetes, 33 outpatients (15 males, 18 females, mean age: 59 yrs) with HbA1c levels of 9.0% or above were instructed to follow a low-carbohydrate diet (1852 kcal; %CHO:fat:protein = 30:44:20) for 6 months in an outpatient clinic and were followed to assess their HbA1c levels, body mass index and doses of antidiabetic drugs. HbA1c levels decreased sharply from a baseline of 10.9 +/-1.6% to 7.8 +/- 1.5% at 3 months and to 7.4 +/- 1.4% at 6 months. Body mass index decreased slightly from baseline (23.8 +/- 3.3) to 6 months (23.5 +/- 3.4). Only two patients dropped out. No adverse effects were observed except for mild constipation. The number of patients on sulfonylureas decreased from 7 at baseline to 2 at 6 months. No patient required inpatient care or insulin therapy. In summary, the 30%-carbohydrate diet over 6 months led to a remarkable reduction in HbA1c levels, even among outpatients with severe type 2 diabetes, without any insulin therapy, hospital care or increase in sulfonylureas. The effectiveness of the diet may be comparable to that of insulin therapy.
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 | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2008 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 02 | 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=R000001054
