Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients (T2DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01735253
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : November 28, 2012
Information provided by (Responsible Party):
Inha University Hospital

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.

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: gastric bypass, duodenojejunal bypass Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
routine GBP with 80cm roux and biliopancreatic limb

Primary Outcome Measures :
  1. Hemoglobin A1C [ Time Frame: preoperatively, at 3month, at 12 month ]
    change of the level

Secondary Outcome Measures :
  1. oral glucose tolerance test [ Time Frame: preopertively, postoperatively, at 3 month, at 12 month ]
    changes of the level at each time

Other Outcome Measures:
  1. insulin level [ Time Frame: preoperatively, postoperatively, at 3 month, at 12 month ]
    change the levels

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01735253

Korea, Republic of
Yoonseok Heo
Incheon, Korea, Republic of, 400-712
Sponsors and Collaborators
Inha University Hospital

Responsible Party: Inha University Hospital, IRB Inha University Hospital Identifier: NCT01735253     History of Changes
Other Study ID Numbers: inha 09-58
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by Inha University Hospital:
metabolic surgery
gastric bypass
duodenojejunal bypass
type 2 DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases