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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000877
Receipt No. 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

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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
Email

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
Email

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001054

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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