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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
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring botulinum toxin, Endoscopy, Satiation, Diet, Weight Loss

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 12, 2014
Last Updated
October 7, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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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

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Intragastric Injections of Botox for the Treatment of Obesity

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