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

Inha University Hospital

Status: Completed

Conditions: Non Insulin Dependent Diabetes Mellitus

Treatments: Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT01735253

inha 09-58

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

gastric bypass, duodenojejunal bypass

Experimental group

Treatment:

Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass