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NCT00694278 Clinical Trial

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

Type II Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00694278
Other study ID # LMC95
Secondary ID
Status Recruiting
Phase Phase 0
First received June 5, 2008
Last updated June 5, 2008
Start date June 2008

Study information
Verified date June 2008
Source Ferzli, George S., M.D. F.A.C.S.
Contact George Ferzli, MD
Phone 718-630-7351
Email gferzli@lmcmc.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 65 Years
Eligibility 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)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Lutheran Medical Center Brooklyn New York

Sponsors (1)
Lead Sponsor Collaborator
Ferzli, George S., M.D. F.A.C.S.

Country where clinical trial is conducted

United States, 

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