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Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Ferzli, George S., M.D. F.A.C.S..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00694278
First Posted: June 10, 2008
Last Update Posted: June 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ferzli, George S., M.D. F.A.C.S.
June 5, 2008
June 10, 2008
June 10, 2008
June 2008
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No Changes Posted
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Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes in Adults
The aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be followed closely to ensure the desired results are sustained in long term
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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Probability Sample
primary care office
Type II Diabetes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
15
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Inclusion Criteria:

  • Adults age 20-65 years
  • Clinical diagnosis of type II diabetes buy on of the following three criteria (American Diabetes Association)

    1. A normal or high C-peptide level (to exclude type 1 diabetes) (>.9ng/ml)
    2. A random plasma glucose of 200mg/dl or more with typical symptom of diabetes
    3. A fasting plasma glucose of 126mg/dl or more on more than one occasion
  • BMI 22-34 KG/m2
  • Patients on oral hypoglycemic medications or insulin to control T2DM
  • Inadequate control of diabetes as defined as HbA1c>7.5
  • No contraindication for surgery or General Anesthesia as determined by multidisciplinary surgical team
  • Ability to understand and describe the mechanism of action of ricks and benefits of the operation

Exclusion Criteria:

  • Patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study
  • Enrolled in another clinical study which involves and investigational drug
  • Diagnosis type 1 diabetes
  • Pregnancy (all female patients will have beta HCG) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method
  • Previous gastric or esophageal surgery
  • Immunosuppressive drugs including corticosteroids
  • Coagulopathy (INR>1.5 or platelets<50,000/ul)
  • Anemia (Hgb<10.0g/dl)
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00694278
LMC95
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Georger Ferzli M.D F.A.C.S., Lutheran Medical Center
Ferzli, George S., M.D. F.A.C.S.
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Study Chair: George Ferzli, MD Lutheran Medical Center
Ferzli, George S., M.D. F.A.C.S.
June 2008