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Clinical Trials/NCT01735253
NCT01735253
Completed
Not Applicable

Metabolic Surgery for Type 2 Diabetes

Inha University Hospital1 site in 1 country20 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non Insulin Dependent Diabetes Mellitus
Sponsor
Inha University Hospital
Enrollment
20
Locations
1
Primary Endpoint
Hemoglobin A1C
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
October 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Inha University Hospital

IRB Inha University Hospital

Inha University Hospital

Eligibility 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

Outcomes

Primary Outcomes

Hemoglobin A1C

Time Frame: preoperatively, at 3month, at 12 month

change of the level

Secondary Outcomes

  • oral glucose tolerance test(preopertively, postoperatively, at 3 month, at 12 month)

Study Sites (1)

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