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

NCT ID: NCT00200018

Last Updated: 2009-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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Severe to Morbid Obesity and Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Enterra Therapy System (H9900014)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedtronicNeuro

INDUSTRY

Sponsor Role lead

Responsible Party

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Medtronic Neuromodulation

Principal Investigators

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ASSIST Team

Role: STUDY_CHAIR

Medtronic

Locations

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La Jolla, California, United States

Site Status

Eagan, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1163-85585

Identifier Type: -

Identifier Source: org_study_id

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