UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012894 |
|---|---|
| Receipt number | R000015037 |
| Scientific Title | Effect of mini-low carbohydrate diet on glucose metabolism in patients with type 2 diabetes: open-label randomized controlled study |
| Date of disclosure of the study information | 2014/01/20 |
| Last modified on | 2016/09/03 10:29:35 |
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Basic information
Public title
Effect of mini-low carbohydrate diet on glucose metabolism in patients with type 2 diabetes: open-label randomized controlled study
Acronym
Effect of mini-low carbohydrate diet on glucose metabolism in patients with type 2 diabetes (EMILY Study)
Scientific Title
Effect of mini-low carbohydrate diet on glucose metabolism in patients with type 2 diabetes: open-label randomized controlled study
Scientific Title:Acronym
Effect of mini-low carbohydrate diet on glucose metabolism in patients with type 2 diabetes (EMILY Study)
Region
| Japan |
Condition
Condition
Type2diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of diet therapy that reduce carbohydrate at dinner and diet therapy with calorie counting with a food exchange list mainly focusing on energy restriction in type 2 diabetes treated with medication or diet therapy only.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in HbA1c
Key secondary outcomes
1. Change in fasting plasma glucose,1,5-Anhydroglucitol,glycated albumin,fasting plasma insulin
2. Change in body weight,waist circumference,body composition and basal energy expenditure.
3. Change in Lipid profile(LDL-C,HDL-C,TG)
4. Level of performance of dietary management(intake energy and nutrition survey)
5. Level of satisfaction with therapy,quality of life(questionary survey)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Moderate diet group
A nationally registered dietitian guides a calorie-restricted diet of 25-30kcal/IBW
day using a food exchange list.Periodic guidance is repeated during the 3months study period.
Interventions/Control_2
Mini low carbohydrate diet group
A nationally registered dietitian guides a diet 25-30kcal/IBW/day for breakfast and lunch.Only carbohydrate is restricted at dinner within same calorie.
Periodic guidance is repeated during the 3months study period.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes.
2. Age more than 20
3. Under treatment with no
antidiabetic agents, or with oral hypoglycemic drugs.
4. Patients with Hb1c less than 8.5%
at entry.
Key exclusion criteria
1. Complication by stage 3A or more
severe diabetic nephropathy, or stage 3 or more severe chronic kidney disease(CKD)not associated
with diabetes.
2. Malignant or acute disease
3. Severe liver disease
4. Decreased pancreatic function due to chronic pancreatitis
5. Hyperthyroidism
6. Adrenal insufficiency
7. Under steroid treatment
8. Patients judged to have difficulty
in performing diabetics on his/her own due to dementia etc.
9. Other patients judged unsuitable by the attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terauchi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura,Kanazawa-ku,Yokohama
TEL
045-787-2800
terauchi@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayo Kimura |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura,Kanazawa-ku, Yokohama
TEL
045-787-2800
Homepage URL
masayo59@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
横浜市立大学附属病院 Yokohama City University
中島内科クリニック Nakajima Naika Clinic
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 20 | 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
| 2014 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 18 | Day |
Last modified on
| 2016 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015037
