Intragastric Injections of Botox for the Treatment of Obesity
Primary Purpose
Obesity, Morbid
Status
Active
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring botulinum toxin, Endoscopy, Satiation, Diet, Weight Loss
Eligibility Criteria
Inclusion Criteria:
- BMI > 35
Exclusion Criteria:
- Known hypersensitivity to medication
- Neuro muscular disease
- Dysphagia
- Tendency for aspiration
- Ulcus
- Use of aminoglycoside antibiotics and/or spectinomycin lately
- Previous side effects of botox injections
- Previous bariatric surgery
- Previous cancer in GI-tract
- Other obesity treatment last 12 months
- Severe eating disorder
- Hypothyroidism
- Pregnancy/brest feeding
- Reduced competence to consent
Sites / Locations
- St. Olavs Hospital, Trondheim University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Botulinum toxin A
Saline solution
Arm Description
Botulinum toxin type A injection in muscles of stomach wall
Placebo (saline solution) injection first 6 months, then active treatment
Outcomes
Primary Outcome Measures
Body weight
Secondary Outcome Measures
Full Information
NCT ID
NCT02035397
First Posted
January 12, 2014
Last Updated
October 7, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02035397
Brief Title
Intragastric Injections of Botox for the Treatment of Obesity
Official Title
Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2014 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run.
There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
botulinum toxin, Endoscopy, Satiation, Diet, Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin A
Arm Type
Experimental
Arm Description
Botulinum toxin type A injection in muscles of stomach wall
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
Placebo (saline solution) injection first 6 months, then active treatment
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Botox
Intervention Type
Drug
Intervention Name(s)
Saline solution
Other Intervention Name(s)
NaCl
Primary Outcome Measure Information:
Title
Body weight
Time Frame
Change from baseline to 6 months; 1 year; 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI > 35
Exclusion Criteria:
Known hypersensitivity to medication
Neuro muscular disease
Dysphagia
Tendency for aspiration
Ulcus
Use of aminoglycoside antibiotics and/or spectinomycin lately
Previous side effects of botox injections
Previous bariatric surgery
Previous cancer in GI-tract
Other obesity treatment last 12 months
Severe eating disorder
Hypothyroidism
Pregnancy/brest feeding
Reduced competence to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bård Kulseng, MD, PhD
Organizational Affiliation
Norwegian University of Science and Technology, Fac MH, IKOM
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Olavs Hospital, Trondheim University Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Intragastric Injections of Botox for the Treatment of Obesity
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