NCT00487526

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2007

Completed
Last Updated

July 11, 2007

Status Verified

July 1, 2007

First QC Date

June 11, 2007

Last Update Submit

July 10, 2007

Conditions

Diabetes Mellitus

Keywords

BypassDuodenal jejunaltype 2 diabetesnon-obese adults

Outcome Measures

Primary Outcomes (1)

  • control of type 2 diabetes in non obese adults

    two years

Secondary Outcomes (1)

  • CCK FFA,Cholesterol,Ghrelin,C-peptide,HbA1c,Gastrin,GIP,Triglycerides,Insulin

    2 years

Interventions

duodenal jejunal bypassPROCEDURE

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Advance Medicine Abel Gonzalez

Santo Domingo, Dominican Republic

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • George S Ferzli, MD F.A.C.S

    SUNY Downstate

    PRINCIPAL INVESTIGATOR

Central Study Contacts

George S Ferzli, MD, F.A.C.S

CONTACT

718-667-8100GFerzli@aol.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 18, 2007

Study Start

June 1, 2007

Last Updated

July 11, 2007

Record last verified: 2007-07

Locations

DO(1)