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

ASSIST: Appetite Suppression Induced by Stimulation Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00200018

Acronym

ASSIST

Enrollment

Registered

2005-09-20

Start date

2005-06-30

Completion date

2007-12-31

Last updated

2009-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe to Morbid Obesity and Type 2 Diabetes

Keywords

Obesity, Morbid obesity, Diabetes

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.

Interventions

DEVICEEnterra Therapy System (H9900014)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean excess weight loss and percent excess weight loss	12 months

Secondary

Measure	Time frame
Diabetes status and use of diabetes medication	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026