Expired Study
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Brooklyn, New York 11220


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


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)


Study is Available At:


Original ID:

LMC95


NCT ID:

NCT00694278


Secondary ID:


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

Phase 0


Genders:

Both


Minimum Age:

20 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

15


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:George Ferzli, MD
Study Chair
Lutheran Medical Center
Primary Contact:George Ferzli, MD
718-630-7351
gferzli@lmcmc.com

Study Dates

Start Date:June 2008
Verification Date:June 2008
Last Changed Date:June 5, 2008
First Received Date:June 5, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ferzli, George S., M.D. F.A.C.S.

Samples and Retentions

Study Population: primary care office
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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