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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inha University Hospital
ClinicalTrials.gov Identifier:
NCT01735253
First received: November 24, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Surgery for Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Inha University Hospital:

Primary Outcome Measures:
  • Hemoglobin A1C [ Time Frame: preoperatively, at 3month, at 12 month ] [ Designated as safety issue: Yes ]
    change of the level


Secondary Outcome Measures:
  • oral glucose tolerance test [ Time Frame: preopertively, postoperatively, at 3 month, at 12 month ] [ Designated as safety issue: Yes ]
    changes of the level at each time


Other Outcome Measures:
  • insulin level [ Time Frame: preoperatively, postoperatively, at 3 month, at 12 month ] [ Designated as safety issue: Yes ]
    change the levels


Enrollment: 20
Study Start Date: December 2009
Study Completion Date: October 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gastric bypass, duodenojejunal bypass Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
routine GBP with 80cm roux and biliopancreatic limb

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735253

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

No publications provided

Responsible Party: Inha University Hospital, IRB Inha University Hospital
ClinicalTrials.gov Identifier: NCT01735253     History of Changes
Other Study ID Numbers: inha 09-58
Study First Received: November 24, 2012
Last Updated: November 27, 2012
Health Authority: Korea: Institutional Review Board

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014