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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 5, 2008

Last Updated Date

June 5, 2008

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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

Detailed Description

Study Phase

Phase 0

Study Type ^†

Observational

Study Design ^†

Case-Only, Cross-Sectional

Condition ^†

Type II Diabetes

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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)

Gender

Both

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: George Ferzli, MD

718-630-7351

gferzli@lmcmc.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00694278

Responsible Party

Georger Ferzli M.D F.A.C.S., Lutheran Medical Center

Secondary IDs ^††

Study Sponsor ^†

Ferzli, George S., M.D. F.A.C.S.

Collaborators ^††

Investigators ^†

Study Chair:

George Ferzli, MD

Lutheran Medical Center

Information Provided By

Ferzli, George S., M.D. F.A.C.S.

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.