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

NCT01735253 | Completed DMC

• 1 other identifier: inha 09-58
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Insulin Dependent Diabetes Mellitus

Keywords

metabolic surgery; gastric bypass; duodenojejunal bypass; type 2 DM

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  change of the level

  preoperatively, at 3month, at 12 month

Secondary Outcomes (1)

• oral glucose tolerance test

  preopertively, postoperatively, at 3 month, at 12 month

Other Outcomes (1)

• insulin level

  preoperatively, postoperatively, at 3 month, at 12 month

Study Arms (1)

gastric bypass, duodenojejunal bypass

EXPERIMENTAL

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

Interventions

laparoscopic roux en Y gastric bypass / open duodenojejunal bypass PROCEDURE

routine GBP with 80cm roux and biliopancreatic limb

gastric bypass, duodenojejunal bypass

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (1)

Yoonseok Heo

Incheon, 400-712, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IRB Inha University Hospital

Study Record Dates

• First Submitted: November 24, 2012
• First Posted: November 28, 2012
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: October 1, 2012
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

KR (1)