Intragastric Injections of Botox for the Treatment of Obesity

NCT02035397 | Unknown Phase 2

• 2 other identifiers: 2013/15972012-004381-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Keywords

botulinum toxin; Endoscopy; Satiation; Diet; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Body weight

  Change from baseline to 6 months; 1 year; 5 years

Study Arms (2)

Botulinum toxin A

EXPERIMENTAL

Botulinum toxin type A injection in muscles of stomach wall

Drug: Botulinum Toxin Type A

Saline solution

PLACEBO COMPARATOR

Placebo (saline solution) injection first 6 months, then active treatment

Drug: Botulinum Toxin Type A; Drug: Saline solution

Interventions

Botulinum Toxin Type A DRUG

Also known as: Botox

Botulinum toxin A; Saline solution

Saline solution DRUG

Also known as: NaCl

Saline solution

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \> 35

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St. Olavs Hospital, Trondheim University Hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bård Kulseng, MD, PhD

  Norwegian University of Science and Technology, Fac MH, IKOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2014
• First Posted: January 14, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

NO (1)