Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients (T2DM)
Primary Purpose
Non Insulin Dependent Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
Sponsored by

About this trial
This is an interventional treatment trial for Non Insulin Dependent Diabetes Mellitus focused on measuring metabolic surgery, gastric bypass, duodenojejunal bypass, type 2 DM
Eligibility Criteria
Inclusion Criteria:
- type 2 diabetes
- 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:
- type 1 diabetes
- 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
Sites / Locations
- Yoonseok Heo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gastric bypass, duodenojejunal bypass
Arm Description
Outcomes
Primary Outcome Measures
Hemoglobin A1C
change of the level
Secondary Outcome Measures
oral glucose tolerance test
changes of the level at each time
Full Information
NCT ID
NCT01735253
First Posted
November 24, 2012
Last Updated
November 27, 2012
Sponsor
Inha University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01735253
Brief Title
Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients
Acronym
T2DM
Official Title
Metabolic Surgery for Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Insulin Dependent Diabetes Mellitus
Keywords
metabolic surgery, gastric bypass, duodenojejunal bypass, type 2 DM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gastric bypass, duodenojejunal bypass
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
Intervention Description
routine GBP with 80cm roux and biliopancreatic limb
Primary Outcome Measure Information:
Title
Hemoglobin A1C
Description
change of the level
Time Frame
preoperatively, at 3month, at 12 month
Secondary Outcome Measure Information:
Title
oral glucose tolerance test
Description
changes of the level at each time
Time Frame
preopertively, postoperatively, at 3 month, at 12 month
Other Pre-specified Outcome Measures:
Title
insulin level
Description
change the levels
Time Frame
preoperatively, postoperatively, at 3 month, at 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 2 diabetes
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:
type 1 diabetes
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
Facility Information:
Facility Name
Yoonseok Heo
City
Incheon
ZIP/Postal Code
400-712
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients
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