CompletedNot Applicable

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

United States46 participantsStarted 2005-06

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean excess weight loss and percent excess weight loss

Timeframe: 12 months

Trial details

NCT IDNCT00200018

SponsorMedtronicNeuro

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-02

View on ClinicalTrials.gov More Severe to Morbid Obesity and Type 2 Diabetes trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.