Botox-treatment of Morbid Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Norwegian University of Science and Technology
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT02035397
First received: January 12, 2014
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Obesity, Morbid
Drug: botox injection
Drug: placebo injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Body weight [ Time Frame: Change from baseline to 6 months; 1 year; 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botox
Botox injection in muscles of stomach wall
Drug: botox injection
Placebo Comparator: Placebo
Placebo injection first 6 months, then active treatment
Drug: placebo injection

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035397

Contacts
Contact: Magnus Strømmen, MSc magnus.strommen@stolav.no

Locations
Norway
St. Olavs Hospital, Trondheim University Hospital Recruiting
Trondheim, Norway, 7006
Sub-Investigator: Gjermund Johnsen, MD         
Sub-Investigator: Ronald Mårvik, MD, PhD         
Sub-Investigator: Duan Chen, MD, PhD         
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Bård Kulseng, MD, PhD St. Olavs Hospital
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02035397     History of Changes
Other Study ID Numbers: 2013/1597, 2012-004381-18
Study First Received: January 12, 2014
Last Updated: July 21, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
botulinum toxin
Endoscopy
Satiation
Diet
Weight Loss

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014