Duodenal Jejunal Bypass for Type 2 Diabetes (DJBD)

• Sponsor: Ferzli, George S., M.D. F.A.C.S. (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00487526
• Collaborator: (none)
• Enrollment: 50
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Procedure: duodenal jejunal bypass	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Effect of Duodenal Jejunal Bypass on Type Two Diabetes in Non Obese Adults
• Study Start Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. control of type 2 diabetes in non obese adults [two years]

Secondary Outcome Measures

1. CCK FFA,Cholesterol,Ghrelin,C-peptide,HbA1c,Gastrin,GIP,Triglycerides,Insulin [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Advance Medicine Abel Gonzalez	Santo Domingo		Dominican Republic

Sponsors and Collaborators

• Ferzli, George S., M.D. F.A.C.S.

Investigators

• Principal Investigator: George S Ferzli, MD F.A.C.S, SUNY Downstate

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00487526
• Other Study ID Numbers: AS07006
• First Posted: Jun 18, 2007
• Last Update Posted: Jul 11, 2007
• Last Verified: Jul 1, 2007

• Keywords provided by , ,: Bypass; Duodenal jejunal; type 2 diabetes; non-obese adults
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Jul 11, 2007