UMIN-CTR Clinical Trial

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

type 2 diabetes, obesity

Classification by specialty

Endocrinology and Metabolism

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

The University of Tokushima

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

徳島大学病院（徳島県）

Date of disclosure of the study information

2014

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

03

Month

11

Day

Last modified on

2014

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015607