UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005716 |
|---|---|
| Receipt number | 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 18:03:08 |
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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
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
yosuke_seki@hotmail.com
Sponsor or person
Institute
Weight Loss and Metabolic Surgery Center
Yotsuya Medical Cube
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006757
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
