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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013396
Receipt No. R000015607
Scientific Title Effect of weight reduction resulting from life style modification or bariatric surgery on pancreas fat accumulation and beta cell function in Japanse type 2 diabetes.
Date of disclosure of the study information 2014/04/01
Last modified on 2014/03/11

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Basic information
Public title Effect of weight reduction resulting from life style modification or bariatric surgery on pancreas fat accumulation and beta cell function in Japanse type 2 diabetes.
Acronym Effect of weight reduction resulting from life style modification or bariatric surgery on pancreas fat accumulation and beta cell function in Japanse type 2 diabetes.
Scientific Title Effect of weight reduction resulting from life style modification or bariatric surgery on pancreas fat accumulation and beta cell function in Japanse type 2 diabetes.
Scientific Title:Acronym Effect of weight reduction resulting from life style modification or bariatric surgery on pancreas fat accumulation and beta cell function in Japanse type 2 diabetes.
Region
Japan

Condition
Condition type 2 diabetes, obesity
Classification by specialty
Endocrinology and Metabolism Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effect of weight reduction resulting from bariatric surgery or life style intervention on insulin secretion and pancreas fat accumulation in Japanese type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1. Insulin secretion before and after intervention.
a. OGTT.
b. Disposition Index (dual glucose clamp method).
2. Glucagon load test before and after intervention.
3. Pancreas fat before and after intervention.
4. Insulin secretion between two groups.
a. OGTT.
b. Disposition Index (dual glucose clamp method).
5. Glucagon load test between two groups.
6. Pancreas fat content between two groups.
7. Correlation between fat content and disposition index.
Key secondary outcomes 1. Change of HbA1c levels before and after intervention.
2. Change of fasting glucagon levels before and after intervention.
3. Change of gastrointestinal hormones before and after intervention.
4. Comparison of HbA1c levels between two groups.
5. Comparison of fasting glucagon levels between two groups.
6. Comparison of gastrointestinal hormones between two groups.

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 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 life style modification
Interventions/Control_2 bariatric surgery
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Insufficient effect of weight loss regardless of 6 month medical therapy.
2. Primary obesity patients aged from 20 to 65 years old.
3. Patients whose BMI levels were higher than 32 kg/m2.
4. Patients whose HbA1c levels were higher than 7.0%.
5. Patients who have diabetes and other obesity related disease; hypertension, liver dysfunction, dyslipidemia.
Key exclusion criteria 1. Diabetes other than type 2 diabetes.
2. Patients who have a disease other than obesity related disease.
3. Patients who have a disease which is associated with the risk of surgery.
4. Patients who have mental disorder.
5. Excessive alcohol drinker.
6. Female patients who are willing to be pregnant and give a birth.
7. Patients who are not willing to lose weight.
8. Patients who are decided to be inadequete for participating this study by physitian in charge.
9. Patients who are decided to have a risk for baritric surgery by physitian in charge.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Munehide Matsuhisa
Organization The university of Tokushima
Division name Diabetes Therapeutics and Research Center
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima
TEL +81-88-633-7587
Email matuhisa@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoyuki Tamaki
Organization The University of Tokushima
Division name Department of Endocrine and Metabolism
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima
TEL +81-88-633-7587
Homepage URL
Email tamaki_m@tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization
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 徳島大学病院(徳島県)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 11 Day
Last modified on
2014 Year 03 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015607

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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