Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients
NCT ID: NCT01735253
Last Updated: 2012-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2009-12-31
2012-10-31
Brief Summary
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We are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.
The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study.
We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.
We will compare the clinical factors at each time.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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gastric bypass, duodenojejunal bypass
laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
routine GBP with 80cm roux and biliopancreatic limb
Interventions
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laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
routine GBP with 80cm roux and biliopancreatic limb
Eligibility Criteria
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Inclusion Criteria
* HbA1C \> 7.0%
* BMI 23 - 34 or BMI 21-22 with viceral obesity
* insulin use less than 10 years
* uncerstanding the risks, hypothesis, expecting effects
Exclusion Criteria
* C-peptide \< 1.0ng/ml
* BMI \< 21
* severe cardiovascular diseases or their history
* malignancy or history
* alcoholics, pituitary failrue
* history of severe ketosis, diabetic coma or precoma
* abnormal liver enzyme, over 3 fold of normal level
* liver cirrhosis or hepatitis
* serum creatinine \> 2.0mg/dL
* glucocorticoids user
* diabetes due to other endocrine diseases
* pancreatic disease
* anti-GAD Ab (+)
* the incongruity for surgery
20 Years
65 Years
ALL
No
Sponsors
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Inha University Hospital
OTHER
Responsible Party
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Inha University Hospital
IRB Inha University Hospital
Locations
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Yoonseok Heo
Incheon, , South Korea
Countries
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Other Identifiers
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inha 09-58
Identifier Type: -
Identifier Source: org_study_id