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

Not Applicable

Completed

• Conditions: Non Insulin Dependent Diabetes Mellitus
• Interventions: Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass

• Registration Number: NCT01735253
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-12
• Study Completion: 2012-10
• Status Verified: 2012-11
• Study First Submitted: 2012-11-24
• Study First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Study First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gastric bypass, duodenojejunal bypass	laparoscopic roux en Y gastric bypass / open duodenojejunal bypass	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	preoperatively, at 3month, at 12 month	change of the level

Secondary Outcome Measures

Name	Time	Method
oral glucose tolerance test	preopertively, postoperatively, at 3 month, at 12 month	changes of the level at each time

Trial Locations

Locations (1)

Yoonseok Heo; 🇰🇷 Incheon, Korea, Republic of