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CompletedNCT00200018ASSISTUpdated Feb 5, 2009

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

An interventional study of Enterra Therapy System (H9900014) in Severe to Morbid Obesity and Type 2 Diabetes, sponsored by MedtronicNeuro. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-02-05.

Sponsored by MedtronicNeuro · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Severe to Morbid Obesity and Type 2 Diabetes

Keywords

  • Obesity
  • Morbid obesity
  • Diabetes
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 46 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

MedtronicNeuro is the lead sponsor of 69 studies on the registry; 2 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Interventions

  • DeviceEnterra Therapy System (H9900014)
06

What researchers measure

Primary outcomes

  1. Mean excess weight loss and percent excess weight loss

    Time frame: 12 months

Secondary outcomes

  1. Diabetes status and use of diabetes medication

    Time frame: 12 months

07

Study locations

2 sites
  • La Jolla, California, United States
  • Eagan, Minnesota, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00200018
Lead sponsor
MedtronicNeuro
First posted
Sep 20, 2005
Start date
Jun 2005
Primary completion
Feb 2007
Completion
Dec 2007
Last update
Feb 5, 2009

Study contacts

ASSIST Team
study chair · Medtronic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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