Severe to Morbid Obesity and Type 2 DiabetesASSISTNCT00200018
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
A study testing Enterra Therapy System (H9900014) in people with Severe to Morbid Obesity and Type 2 Diabetes, run by MedtronicNeuro at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Severe to Morbid Obesity and Type 2 Diabetes
- What is being tested?
- Enterra Therapy System (H9900014)
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2005to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Eagan, Minnesota
Study site
La Jolla, California
About this study
Official title: ASSIST: Appetite Suppression Induced by Stimulation Trial
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.
- Being tested
- Enterra Therapy System (H9900014)
- Keywords
- Obesity, Morbid obesity, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Obesity, Morbid, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterra Therapy System (H9900014)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean excess weight loss and percent excess weight loss
Measured: 12 months
Secondary outcomes (1)
Diabetes status and use of diabetes medication
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionFeb 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe to Morbid Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ASSIST Team, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200018
- Sponsor's protocol ID
- 1163-85585
- Acronym
- ASSIST
- Status last verified
- Feb 2009
- First submitted
- 12 Sep 2005
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSIST: Appetite Suppression Induced by Stimulation Trial
- ClinicalTrials.gov ID
- NCT00200018
- Acronym / sponsor ID
- ASSIST / 1163-85585
- Keywords
- Obesity, Morbid obesity, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enterra Therapy System (H9900014) | Device | – |
Primary outcome
Mean excess weight loss and percent excess weight loss
Time frame: 12 months
1 secondary outcome
Diabetes status and use of diabetes medication
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
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Type 2 Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ASSIST Team study chair
Medtronic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterra Therapy System (H9900014) in people with Severe to Morbid Obesity and Type 2 Diabetes, run by MedtronicNeuro at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean excess weight loss and percent excess weight loss (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.