Duodenal Exclusion for the Treatment of T2DM | NCT00456352

Studies
Duodenal Exclusion for the Treatment of T2DM

NCT00456352

Sponsor

Medtronic - MITG

Status

Completed

Last Update Posted

Aug 22, 2014Estimated

Enrollment

37Actual

Phase

Phase 4

Conditions

Diabetes

Interventions

duodenal exclusion

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Oct 2010Actual

First Submitted Date

Apr 2, 2007

First Submission Date that Met QC Criteria

Apr 2, 2007

First Posted Date

Apr 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2014

Last Update Posted Date

Aug 22, 2014Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Name	Type	Description	Arm Group Labels	Other Names
duodenal exclusion	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment success based on patients' glycemic control.		2 weeks, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes

Measure	Description	Time Frame
Physiologic measurements, Comorbidity improvement, Improvement in QOL.		2 weeks, 3 months, 6 months, 9 months, 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Noreen A Gannon	Medtronic - MITG	Study Director
Ricardo Cohen, MD	Hospital São Camilo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital São Camilo		São Paulo			Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided