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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Ferzli, George S., M.D. F.A.C.S..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ferzli, George S., M.D. F.A.C.S.
ClinicalTrials.gov Identifier:
NCT00694278
First received: June 5, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

June 5, 2008
June 5, 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.
 
Recruiting
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)
Both
20 Years to 65 Years
Yes
Contact: George Ferzli, MD 718-630-7351 gferzli@lmcmc.com
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP