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NCT00487526 Clinical Trial

Duodenal Jejunal Bypass for Type 2 Diabetes (DJBD)

Diabetes Mellitus Clinical Trial

— DJBD  

Official title:
Clinical Evaluation of the Effect of Duodenal Jejunal Bypass on Type Two Diabetes in Non Obese Adults

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00487526
Other study ID # AS07006
Secondary ID
Status Recruiting
Phase Phase 1
First received June 11, 2007
Last updated July 10, 2007
Start date June 2007

Study information
Verified date July 2007
Source Ferzli, George S., M.D. F.A.C.S.
Contact George S Ferzli, MD, F.A.C.S
Phone 718-667-8100
Email GFerzli@aol.com
Is FDA regulated No
Health authority Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)
Study type Interventional

Clinical Trial Summary

Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes.

Description:

Adults non obese ( BMI less than 34 ) will undergo duodenal jejunal bypass. The Outcome measures: Blood Sugar, Insulin,HbA1c, CCK,Gastrin, GIP1and 2, Ghrelin, Cholesterol, Triglycerides,FFA, C-Peptide.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Adults age 20-65

- Clinical diagnosis of type 2 diabetes

- Non obese with BMI less than 34.

- Oral agents or insulin to control T2DM.

- Inadequate control of diabetes as defined as HbA1c>/7.5

- Understanding of the mechanisms of action of the treatment

Exclusion Criteria:

- Children with type 1 diabetes

- Obese with BMI over 34

- Coagulopathy

- Liver cirrhosis

- Unable to comply with study requirements, follow-up or give valid consent

- Currently pregnant

- Previous upper abdominal surgery

- Inabilty to tolerate general anesthesia

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• duodenal jejunal bypass

Locations
Country Name City State
Dominican Republic Center for Advance Medicine Abel Gonzalez Santo Domingo

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

Country where clinical trial is conducted

Dominican Republic, 

Outcome
Type Measure Description Time frame Safety issue
Primary control of type 2 diabetes in non obese adults two years
Secondary CCK FFA,Cholesterol,Ghrelin,C-peptide,HbA1c,Gastrin,GIP,Triglycerides,Insulin 2 years
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