Non Insulin Dependent Diabetes Mellitus
Conditions
Keywords
metabolic surgery, gastric bypass, duodenojejunal bypass, type 2 DM
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.
Interventions
PROCEDURElaparoscopic roux en Y gastric bypass / open duodenojejunal bypass
routine GBP with 80cm roux and biliopancreatic limb
Sponsors
Inha University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | preoperatively, at 3month, at 12 month | change of the level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| oral glucose tolerance test | preopertively, postoperatively, at 3 month, at 12 month | changes of the level at each time |
Other
| Measure | Time frame | Description |
|---|---|---|
| insulin level | preoperatively, postoperatively, at 3 month, at 12 month | change the levels |
Countries
South Korea
Outcome results
None listed