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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.
  Purpose
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

Condition Phase
Type II Diabetes Early Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes in Adults

Further study details as provided by Ferzli, George S., M.D. F.A.C.S.:

Estimated Enrollment: 15
Study Start Date: June 2008
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
primary care office
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694278


Contacts
Contact: George Ferzli, MD 718-630-7351 gferzli@lmcmc.com

Locations
United States, New York
Lutheran Medical Center Recruiting
Brooklyn, New York, United States, 11220
Contact: George Ferzli, MD    718-630-7351      
Sponsors and Collaborators
Ferzli, George S., M.D. F.A.C.S.
Investigators
Study Chair: George Ferzli, MD Lutheran Medical Center
  More Information

Responsible Party: Georger Ferzli M.D F.A.C.S., Lutheran Medical Center
ClinicalTrials.gov Identifier: NCT00694278     History of Changes
Other Study ID Numbers: LMC95
First Submitted: June 5, 2008
First Posted: June 10, 2008
Last Update Posted: June 10, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases