- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01735253
Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients (T2DM)
Metabolic Surgery for Type 2 Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Incheon, Korea, Republic of, 400-712
- Yoonseok Heo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: gastric bypass, duodenojejunal bypass
|
routine GBP with 80cm roux and biliopancreatic limb
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1C
Time Frame: preoperatively, at 3month, at 12 month
|
change of the level
|
preoperatively, at 3month, at 12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oral glucose tolerance test
Time Frame: preopertively, postoperatively, at 3 month, at 12 month
|
changes of the level at each time
|
preopertively, postoperatively, at 3 month, at 12 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
insulin level
Time Frame: preoperatively, postoperatively, at 3 month, at 12 month
|
change the levels
|
preoperatively, postoperatively, at 3 month, at 12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- inha 09-58
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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