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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027262
Receipt No. R000031165
Scientific Title Food in Eu(iso)-Energic Diet in Nutritional Glucose Manipulate urinary Elimination
Date of disclosure of the study information 2017/05/08
Last modified on 2019/03/28

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Basic information
Public title Food in Eu(iso)-Energic Diet in
Nutritional Glucose Manipulate urinary
Elimination
Acronym FEEDING-ME
Scientific Title Food in Eu(iso)-Energic Diet in
Nutritional Glucose Manipulate urinary
Elimination
Scientific Title:Acronym FEEDING-ME
Region
Japan

Condition
Condition diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For type 2 diabetes patients with severe hyperglycemia,the sodium glucose
transporter 2 inhibitor or eliminated
carbohydrate diet which is equal to
urinary glucose caused by SGLT2 inhibitor will be added to insulin intensive
therapy.
It is intended to be compared movement of consumptive energy before and after meal, also,effects of reduction of blood
glucose between two groups.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes respiratory quotient and energy
consumption of meal tolerance test by
indirect calorimetry
(pre research period,post 7days,
12weeks at the research period)
Key secondary outcomes 1. total insulin use and period until
normal blood glucose response
(fasting blood glucose less than 110mg/dl,average plasma glucose less than 126mg/dl)
2. index of blood glucose control:
change of casual blood glucose by self
monitoring blood glucose during research
period
3. index of blood ketone body:casual
beta-Hydroxybutyric acid measured by
beta-ketone body measuring-instrument and
total ketone body measured by clinical
test during research period
4. changes of body weight,blood pressure,
and body mass index during research period
5. change of urine volume,urination
frequency, urinary glucose per day
during research period
6. an index of lipid parameters(total
cholesterol,triglyceride,HDL cholesterol,
LDL cholesterol)(pre research period,
post 7days,4weeks,8weeks,12weeks at the
research period)
7. pancreas beta cell function:plasma CPR etc.(pre research period,post 7days,
12weeks at the research period)
8. degree of satisfaction of treatment:
questionnaire with Diabetes
Therapy-Related QOL (DTR-QOL)
(pre research period,post 12weeks at the
research period)
9.neurological evaluation of energy
metabolism of meal tolerance test
(pre research period,post 12weeks at the
research period)
10. evaluation of safety:Symptoms of
hypoglycemia or hyperglycemia,digestive
or other harmful phenomenon,abnormal
data of clinical exam during research
period
11.change of plasma marker of energy
metabolism, various carbonic acid
concentration and body composition
(pre research period,post 7days,
12weeks at the research period)
12.evaluation of compliance of
nutritional intake by BDHQ
(pre research period,post 4weeks,12 weeks at the research period)
13.evaluate changes of blood glucose,the
marker of carbohydrate and lipid
metabolism,during meal tolerance test.
(pre research period,post 7days,12 weeks
at the research period)


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 Insulin intensive therapy
(insulin aspart,insulin glargine BS)
Diet therapy(28kcal/kg)
Interventions/Control_2 Insulin intensive therapy
(insulin aspart,insulin glargine BS)
Diet therapy(28kcal/kg)
Drug therapy Canagliflozin (100mg/day)
Interventions/Control_3 Insulin intensive therapy
(insulin aspart,insulin glargine BS)
Diet therapy(25kcal/kg,carbo ratio 60%
and about -50g/day)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Insulin independent Type 2 diabetes
patients controlled inadequately with
HbA1c more than 8.0%
2. Patients who does not use human GLP-1
analog or insulin or SGLT2 inhibitor
3. Patients who can understand consent
brief and other explanation documents
having the ability of the agreement about participation in this examination
Key exclusion criteria 1.Type 1 diabetes mellitus patients or
secondary diabetic mellitus
2.Patients who had myocardial infarction
within 3 months,or obvious heart failure
case
3.Patients who had the past
hypersensitivity for the used drug
4.Patients with diabetic ketoacidosis or
diabetic coma or risk of diabetic coma
5.Patients with severe liver disease
6.Patients with severe renal disease
7.Patients with severe pancreas disease
8.Patients during cancer treatment
9.Patients with hemoglobin (Hb) less than 11g/dL
10.Patients that the number of the
platelets is less than 100,000 /mm3
11.Patients with severe diabetic
neuropathy
12.Patients having a proliferative
retinopathy
13.Patients with a serious infectious
disease or during a surgery period or
a serious injury
14.Excessive common custom drinker
15.A pregnant woman or the woman who may
be pregnant
16.In addition, the patients who will be
judged inappropriate by an attendant
physician

Target sample size 39

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirose Takahisa
Organization Toho University School of Medicine
Division name Division of diabetes,metabolism and endocrinology
Zip code
Address 6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL 03-3762-4151(6560.6565)
Email takahisa.hirose@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Igarashi
Organization Toho University School of Medicine
Division name Division of diabetes,metabolism and endocrinology
Zip code
Address 6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan
TEL 03-3762-4151(6560.6565)
Homepage URL
Email hiroyuki.igarashi@med.toho-u.ac.jp

Sponsor
Institute Toho University School of Medicine
Division of diabetes,metabolism and
endocrinology
Institute
Department

Funding Source
Organization Mitubishi Tanabe Pharma Corporation
Ikuyaku Integrated Value Development
division of research and Ikuyaku
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 東邦大学医療センター大森病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 08 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
2016 Year 04 Month 12 Day
Date of IRB
2016 Year 11 Month 17 Day
Anticipated trial start date
2017 Year 05 Month 09 Day
Last follow-up date
2019 Year 01 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 07 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031165

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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