Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients (T2DM)
|ClinicalTrials.gov Identifier: NCT01735253|
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : November 28, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Non Insulin Dependent Diabetes Mellitus||Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic Surgery for Type 2 Diabetes|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||October 2012|
|Experimental: gastric bypass, duodenojejunal bypass||
Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
routine GBP with 80cm roux and biliopancreatic limb
- Hemoglobin A1C [ Time Frame: preoperatively, at 3month, at 12 month ]change of the level
- oral glucose tolerance test [ Time Frame: preopertively, postoperatively, at 3 month, at 12 month ]changes of the level at each time
- insulin level [ Time Frame: preoperatively, postoperatively, at 3 month, at 12 month ]change the levels
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735253
|Korea, Republic of|
|Incheon, Korea, Republic of, 400-712|