NCT00456352

Brief Summary

Evaluation of duodenal exclusion procedure for the treatment of T2DM

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

April 2, 2007

Last Update Submit

August 21, 2014

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Treatment success based on patients' glycemic control.

    2 weeks, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (1)

  • Physiologic measurements, Comorbidity improvement, Improvement in QOL.

    2 weeks, 3 months, 6 months, 9 months, 12 months

Interventions

duodenal exclusionPROCEDURE

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 65 years
  • BMI between 23 and 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:

  • More than 10 years of T2DM diagnosis
  • More than 7 years of insulin use
  • Previous abdominal operations
  • Coagulopathy
  • Liver cirrhosis
  • Unable to comply with study requirements, follow-up schedule or give valid consent.
  • Currently pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Camilo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Noreen A Gannon

    Medtronic - MITG

    STUDY DIRECTOR

  • Ricardo Cohen, MD

    Hospital São Camilo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 4, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

October 1, 2010

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations

BR(1)