Weight loss before weight loss surgery in patients with fatty liver
Phase 1
- Conditions
- Obesity and NAFLD can increase the risk and complexity of bariatric surgery up to 20%. Reducing the weight and liver size before bariatric surgery improves the operation area and reduces complications after the procedure.Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2020-000220-19-AT
- Lead Sponsor
- Verein zur Förderung von Wissenschaft und Forschung an der 1. Med. Abteilung der Krankenanstalt Rudolfstiftung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
BMI > 40 kg/m2, NAFLD-diagnosis, Age: 18-60
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 62
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Type 1 Diabetes, liver cirrhosis, medication that cause weight loss or gain, use of GLP-1-Analoga or DPPIV-inhibitor
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: weight loss before bariatric surgery ;Secondary Objective: liver size reduction;Primary end point(s): weight loss before bariatric surgery ;Timepoint(s) of evaluation of this end point: after 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): liver size reduction;Timepoint(s) of evaluation of this end point: after 12 weeks