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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005716
Receipt No. R000006757
Scientific Title Laparoscopic sleeve gastrectomy with duonenal-jejunal bypass for Asian type 2 diabetics with BMI from 27.5 kg/m2 to 34.9 kg/m2: A prospective, non-randomized, single center, open label study
Date of disclosure of the study information 2011/06/03
Last modified on 2019/12/10

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Basic information
Public title Laparoscopic sleeve gastrectomy with duonenal-jejunal bypass for Asian type 2 diabetics with BMI from 27.5 kg/m2 to 34.9 kg/m2: A prospective, non-randomized, single center, open label study
Acronym Laparoscopic sleeve gastrectomy with duonenal-jejunal bypass for Asian type 2 diabetics with BMI from 27.5 kg/m2 to 34.9 kg/m2
Scientific Title Laparoscopic sleeve gastrectomy with duonenal-jejunal bypass for Asian type 2 diabetics with BMI from 27.5 kg/m2 to 34.9 kg/m2: A prospective, non-randomized, single center, open label study
Scientific Title:Acronym Laparoscopic sleeve gastrectomy with duonenal-jejunal bypass for Asian type 2 diabetics with BMI from 27.5 kg/m2 to 34.9 kg/m2
Region
Japan

Condition
Condition Asian type 2 diabetics with BMI from 27.5 kg/m2 to 34.9 kg/m2
Classification by specialty
Gastrointestinal surgery Endocrine surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study examines Asian type 2 diabetics with BMI from 27.5 to 34.9 kg/m2. In this population, what is the relative effectiveness of laparoscopic sleeve gastrectomy with duodenal jejunal bypass in reducing diabetes and CVD risk factor?
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome will be assessed at 1 year, and will be a composite of parameters of optimal diabetes management: glycosylated hemoglobin (HbA1c) < 7.0%, fasting LDL cholesterol < 100 mg/dl and systolic blood pressure < 130 mmHg.
Key secondary outcomes The secondary outcomes will be assessed 1 year after the intervention begins.
1. Changes in weight and BMI, waist circumference, fasting glucose, fasting insulin, lipid profile (serum
total cholesterol, HDL cholesterol, and triglycerides)
2. Changes in urine microalbumin/creatinine ratio and resolution of co-morbid renal function illness.
3. Use of medications (as measured by dosages and cost)
4. Total cost of diabetes- and CVD-related health care
5. Measures from three surveys: Quality of life (SF-36), depression (CES-D), and a brief version
Questionnaire for Eating and Weight Patterns-Revised (QEWP-R) to assess binge eating disorder. The
surveys will be collected at the baseline, 6 months, and 12 months.
6. Mortality
7. Cardiovascular events (myocardial infarction, stroke, other serious CVD)
8. Complications from surgery

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
Maneuver
Interventions/Control_1 Laparoscopic sleeve gastrectomy with duodenal jejunal bypass
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria (1) Age 20 to 65 years at eligibility visit. (2) Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the 6 months prior to enrollment. (4)HbA1c equal to or more than 8.0% at eligibility visit. (4) 27.5 kg/m2<Body Mass Index (BMI) <34.9 kg/m2 at eligibility visit. (5) Willingness to comply with the follow-up protocol. (5) Written informed consent.
Key exclusion criteria (1) Cardiovascular event in the past 6 months. (2) Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. (3) Cardiac stress test indicating that surgery would not be safe. (4) Pulmonary embolus or thrombophlebitis in the past 6 months. (5) Cancer of any kind unless documented to be disease-free for 5 years. (6) Significant anemia (hemoglobin 1.0 g or
more below normal range) or history of coagulopathy. (7) Serum creatinine less than 1.5 mg/dl. (8) Serum total bilirubin greater than the upper limit of normal, or alkaline phosphatase or ALT greater than twice the upper limit of normal. (9) History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy,
or colon resection. (10) Gastric or duodenal ulcer in the past 6 months. (11) History of intra-abdominal sepsis. (12) Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease. (13) Currently pregnant or nursing, or planning to become pregnant in the next 2 years. (14) History of alcohol or drug dependency in the past 5 years. (15) Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. (16)
Presence of any chronic or debilitating disease that would make adherence to the protocol difficult. (17) 12-lead EKG indicating that surgery would not be safe. (18) Serum fasting c-peptide less than 1.0 ng/ml. (19) Exclusions may also be made at the discretion of the attending physician.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kasama
Middle name
Last name Kazunori
Organization Yotsuya Medical Cube
Division name Weight Loss and Metabolic Surgery Center
Zip code 102-0084
Address 7-7 Nibancho, Chiyoda-ku, Tokyo 102-0084, Japan
TEL 03-3261-0401
Email kasama@mcube.jp

Public contact
Name of contact person
1st name Seki
Middle name
Last name Yosuke
Organization Yotsuya Medical Cube
Division name Weight Loss and Metabolic Surgery Center
Zip code 02-0084
Address 7-7 Nibancho, Chiyoda-ku, Tokyo 102-0084, Japan
TEL 03-3261-0401
Homepage URL
Email yosuke_seki@hotmail.com

Sponsor
Institute Weight Loss and Metabolic Surgery Center
Yotsuya Medical Cube
Institute
Department

Funding Source
Organization not funded
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Center for Global Health and Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yotsuya Medical Cube
Address 7-7 Nibancho, Chiyoda-ku, Tokyo 102-0084, Japan
Tel 03-3261-0401
Email h-satoh@mcube.jp

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 四谷メディカルキューブ(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 03 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 Open public recruiting
Date of protocol fixation
2011 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 03 Day
Last modified on
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006757

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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