Treatment of morbid obesity through stomach injections of Botulinum toxin A: A pilot study
- Conditions
- Morbid obesity (obesity class 3)Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-004381-18-NO
- Lead Sponsor
- St Olavs Hospital Trondheim University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Adult (18-60 years) volunteers with morbid obesity (BMI > 40 kgs/m2, or BMI > 35 kgs/m2 if obesity related comorbidity, accepted for bariatric surgery)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-Previous side-effects from botox injections
-Previous bariatric surgery
-Previous cancer disease in the GI-tract
-Other obesity treatment the last 3 mts (drug or lifestyle-based)
-Severe binge-eating disorder
-Hypothyroidism
-Pregnancy
-Inadequate capacity to consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: A proof-of-concept study of the effect of intragastric injection of Botulinum toxin A on weight loss in morbidly obese patients. The study will provide basis for calculating sample size for a future double-blinded randomized controlled trial. To do so we need experience with the degree and variability of weight loss;Secondary Objective: not applicable;Primary end point(s): body weight;Timepoint(s) of evaluation of this end point: at baseline, 4 weeks, 8 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Laboratory:<br>-Hb, HbA1c, glucose, C-peptide, Na, K, creatinine, HDL, LDL, total-kolesterol, triglycerids, HS-CRP, ALAT<br>Clinical tests:<br>-Blood pressure , ECG<br>Anthropometry:<br>-Height, weight, BodPod (body composition)<br>Questionnaires:<br>-Symptoms (Gastrointestinal Symptom Rating Scale), Hunger/satiety, Food diary;Timepoint(s) of evaluation of this end point: at baseline, 4 weeks, 8 weeks