UMIN-CTR Clinical Trial
| 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 (Ver. 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 |
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| Condition | |||
| Condition | Asian type 2 diabetics with BMI from 27.5 kg/m2 to 34.9 kg/m2 | ||
| Classification by specialty |
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| 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 |
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| Interventions/Control_1 | Laparoscopic sleeve gastrectomy with duodenal jejunal bypass | |
| Interventions/Control_2 | ||
| Interventions/Control_3 | ||
| Interventions/Control_4 | ||
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| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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. |
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| Target sample size | 50 | |||
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| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 |
| 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） |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Unpublished |
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| Baseline Characteristics | |
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| IPD sharing Plan description | |
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| Recruitment status | Open public recruiting | ||||||
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006757 |
