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

Sponsor

Inha University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01735253

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Metabolic Surgery for Type 2 Diabetes

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Hemoglobin A1C [preoperatively, at 3month, at 12 month]
change of the level

Secondary Outcome Measures

oral glucose tolerance test [preopertively, postoperatively, at 3 month, at 12 month]
changes of the level at each time

Other Outcome Measures

insulin level [preoperatively, postoperatively, at 3 month, at 12 month]
change the levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yoonseok Heo	Incheon		Korea, Republic of	400-712

Sponsors and Collaborators

Inha University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Inha University Hospital, IRB Inha University Hospital, Inha University Hospital

ClinicalTrials.gov Identifier:

NCT01735253

Other Study ID Numbers:

inha 09-58

First Posted:

Nov 28, 2012

Last Update Posted:

Nov 28, 2012

Last Verified:

Nov 1, 2012

Keywords provided by Inha University Hospital, IRB Inha University Hospital, Inha University Hospital

metabolic surgery

gastric bypass

duodenojejunal bypass

type 2 DM

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 28, 2012