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

N/ACompletedNCT00200018

MedtronicNeuro46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Severe to Morbid Obesity and Type 2 Diabetes

Interventions

Enterra Therapy System (H9900014)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

La Jolla, California, United States

Unnamed facility

Eagan, Minnesota, United States

Outcomes

Primary Outcomes

Mean excess weight loss and percent excess weight loss

Time frame: 12 months

Secondary Outcomes

Diabetes status and use of diabetes medication

Time frame: 12 months

Data from ClinicalTrials.gov

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