ObesityPhase 1NCT00976443
Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects
A Phase 1 study testing BTA in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- BTA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2011
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 years and ≤ 60 years
- BMI ≥ 35 kg /m²
- No history of diabetes, gastric or small bowel surgery, known gastroparesis, prior peptic ulcer, esophagitis, or gastrointestinal stricture.
- Not pregnant or nursing. Women of childbearing potential must have a negative urine pregnancy test within 48 hours prior to each gastric emptying study, and the Botox injection procedure.
Who cannot join
- Unable or unwilling to provide written informed consent
- ASA Class III or higher
- Chronic upper abdominal pain, nausea, or vomiting
- Allergy to botulinum toxin
- Delayed gastric emptying (abnormal T ½) on baseline scintigraphic gastric emptying test
- Active esophageal, gastric, or duodenal ulceration at time of diagnostic EGD
- Allergic to both penicillins AND quinolones
- Subject has taken warfarin (Coumadin) or clopidogrel (Plavix) in the week preceding EUS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections
Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This protocol is designed to study the effects and safety of gastric BTA injections. Subjects are randomized to receive placebo or one of two different doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric intake are recorded before and after injections, and subjects are seen in follow-up for 24 weeks.
Read the detailed description
Additional information regarding study interventions can be obtained by contacting study staff.
- Conditions
- Obesity
- Being tested
- BTA, Placebo (normal saline)
- Keywords
- Obesity, Gastric Emptying, Satiation, Endosonography, Endoscopy, Feeding Behavior
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTADrug
Also called Botox
BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum
Placebo (normal saline)Drug
Placebo (normal saline), gastric injections of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo (normal saline) | Placebo comparator | Gastric injections of normal saline Receives: Drug: Placebo (normal saline) |
| BTA 100 U | Active comparator | Gastric injections of botulinum toxin A, 100 Units Receives: Drug: BTA |
| BTA 300 U | Active comparator | BTA 300 U, gastric injections under EUS guidance Receives: Drug: BTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight between baseline and 16 weeks after BTA injection.
Measured: 16 weeks
Secondary outcomes (4)
Change in BMI and waist circumference
Measured: 16 weeks
Change in gastric emptying T½
Measured: Baseline to 2 weeks
Change in nutrient drink test maximum tolerated volume (MTV)
Measured: 16 weeks
Change in gastrointestinal symptoms over time
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Topazian, Mayo Clinic
- Investigators
- Mark Topazian, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976443
- Sponsor's protocol ID
- 09-000002
- Status last verified
- Jan 2013
- First submitted
- 11 Sep 2009
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Topazian M, Camilleri M, De La Mora-Levy J, Enders FB, Foxx-Orenstein AE, Levy MJ, Nehra V, Talley NJ. Endoscopic ultrasound-guided gastric botulinum toxin injections in obese subjects: a pilot study. Obes Surg. 2008 Apr;18(4):401-7. doi: 10.1007/s11695-008-9442-x. Epub 2008 Feb 20.
PubMed 18286347Topazian M, Camilleri M, Enders FT, Clain JE, Gleeson FC, Levy MJ, Rajan E, Nehra V, Dierkhising RA, Collazo-Clavell ML, Talley NJ, Clark MM. Gastric antral injections of botulinum toxin delay gastric emptying but do not reduce body weight. Clin Gastroenterol Hepatol. 2013 Feb;11(2):145-50.e1. doi: 10.1016/j.cgh.2012.09.029. Epub 2012 Oct 9.
PubMed 23063681
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Effects of High-Dose Gastric Antral Botulinum Toxin Injections
- ClinicalTrials.gov ID
- NCT00976443
- Acronym / sponsor ID
- 09-000002
- Conditions
- Obesity
- Keywords
- Obesity, Gastric Emptying, Satiation, Endosonography, Endoscopy, Feeding Behavior
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Sep 2009 (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.
Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This protocol is designed to study the effects and safety of gastric BTA injections. Subjects are randomized to receive placebo or one of two different doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric intake are recorded before and after injections, and subjects are seen in follow-up for 24 weeks.
Detailed description
Additional information regarding study interventions can be obtained by contacting study staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (normal saline) | Placebo comparator | Drug: Placebo (normal saline)Gastric injections of normal saline |
| BTA 100 U | Active comparator | Drug: BTAGastric injections of botulinum toxin A, 100 Units |
| BTA 300 U | Active comparator | Drug: BTABTA 300 U, gastric injections under EUS guidance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and ≤ 60 years
- BMI ≥ 35 kg /m²
- No history of diabetes, gastric or small bowel surgery, known gastroparesis, prior peptic ulcer, esophagitis, or gastrointestinal stricture.
- Not pregnant or nursing. Women of childbearing potential must have a negative urine pregnancy test within 48 hours prior to each gastric emptying study, and the Botox injection procedure.
Key exclusion criteria (8 listed)
- Unable or unwilling to provide written informed consent
- ASA Class III or higher
- Chronic upper abdominal pain, nausea, or vomiting
- Allergy to botulinum toxin
- Delayed gastric emptying (abnormal T ½) on baseline scintigraphic gastric emptying test
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 |
|---|---|---|
| BTAAlso: BotoxBTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum | Drug | BTA 100 U, BTA 300 U |
| Placebo (normal saline)Placebo (normal saline), gastric injections of normal saline | Drug | Placebo (normal saline) |
Primary outcome
Change in body weight between baseline and 16 weeks after BTA injection.
Time frame: 16 weeks
4 secondary outcomes
Change in BMI and waist circumference
Time frame: 16 weeks
Change in gastric emptying T½
Time frame: Baseline to 2 weeks
Change in nutrient drink test maximum tolerated volume (MTV)
Time frame: 16 weeks
Change in gastrointestinal symptoms over time
Time frame: 24 weeks
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 3 Jan 2013.
- Background: PubMed 18286347Topazian M, Camilleri M, De La Mora-Levy J, Enders FB, Foxx-Orenstein AE, Levy MJ, Nehra V, Talley NJ. Endoscopic ultrasound-guided gastric botulinum toxin injections in obese subjects: a pilot study. Obes Surg. 2008 Apr;18(4):401-7. doi: 10.1007/s11695-008-9442-x. Epub 2008 Feb 20.
- Derived from this study: PubMed 23063681Topazian M, Camilleri M, Enders FT, Clain JE, Gleeson FC, Levy MJ, Rajan E, Nehra V, Dierkhising RA, Collazo-Clavell ML, Talley NJ, Clark MM. Gastric antral injections of botulinum toxin delay gastric emptying but do not reduce body weight. Clin Gastroenterol Hepatol. 2013 Feb;11(2):145-50.e1. doi: 10.1016/j.cgh.2012.09.029. Epub 2012 Oct 9.
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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.
Mark Topazian, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BTA in people with Obesity, run by Mayo Clinic at 1 site 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 8 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 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in body weight between baseline and 16 weeks after BTA injection. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00976443, which also lists 2 linked publications.
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 3 Jan 2013.