Study of Weight Loss Using Gastric Stimulation in Obese P... | NCT00200018

Studies
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes

NCT00200018

Sponsor

MedtronicNeuro

Status

Completed

Last Update Posted

Feb 5, 2009Estimated

Enrollment

46Actual

Phase

Not Applicable

Conditions

Severe to Morbid Obesity and Type 2 Diabetes

Interventions

Enterra Therapy System (H9900014)

Countries

United States

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

Feb 2009

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

Jun 2005

Primary Completion Date

Feb 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

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

Feb 3, 2009

Last Update Posted Date

Feb 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to test the effect of an implanted device that stimulates the stomach on weight loss in patients suffering from obesity and type 2 diabetes.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Name	Type	Description	Arm Group Labels	Other Names
Enterra Therapy System (H9900014)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean excess weight loss and percent excess weight loss		12 months

Secondary Outcomes

Measure	Description	Time Frame
Diabetes status and use of diabetes medication		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes with HbA1c of 7.5 - 11%
Willing to make behavior and lifestyle modifications
No previous bariatric surgery (gastric bypass, gastric banding)
Meet additional study criteria

Exclusion Criteria:

History of substance abuse or chemical dependency with in the last 3 years
Prior GI surgery for morbid obesity or any gastric surgery for conditions other than obesity or diabetes
Severe congestive heart failure
Any underlying illness other than diabetes or obesity that affects gastrointestinal motility
Currently taking medications for weight loss

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
ASSIST Team	Medtronic	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity
D009767	Obesity, Morbid
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

Facility	Status	City	State	ZIP	Country	Contacts
		La Jolla	California		United States