Obesity, Adolescent
Conditions
Keywords
Obesity, Bariatric surgery, metabolic surgery, liraglutide, saxenda, weight loss, surgery risk reduction, excess weight loss
Brief summary
The aim of the study is to investigate the effects of preoperative Saxenda (liraglutide). There are two groups, one group receives Saxena in addition to dietary measures when first seeking the operation, one group only diet. The investigator is researching how much additional preoperative weight loss is possible with the drug admitted preoperatively.
Detailed description
The aim of the study is to investigate the effects of preoperative Saxenda (liraglutide). There are two groups, one group receives Saxena in addition to dietary measures, one group only diet. Each group will have a waiting period of 6 months until the operation will be done. The investigator wants to elaborate how much additional preoperative weight loss is possible with the drug. The greater the preoperative weight loss, the lower the risk of the operation. After one year, the investigator will also check whether the weight loss has been maintained and whether the preoperative Saxenda continues to lose even more weight after the operation. All patients looking for bariatric surgery with health insurance via Österreichische Gesundheitsklasse and BMI\>35kg/m2 will be asked to take part in this study. Patients with previous bariatric surgeries or contraindications against liraglutide will be excluded from this study.
Interventions
DRUGLiraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions
Liraglutide daily (0.6-3.0mg, highest tolerable dose) as additional preoperative method for weight loss
BEHAVIORALDietologic measures and lifestyle optimization for weight loss
all subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking Description
Intervention model description
Randomized controlled trial, open
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients seeking bariatric surgery * BMI \> 35.0 kg/m2 * Health insurance via Österreichische Gesundheitskasse * Willingness to be assigned to either of the two groups * Willingness to adhere to preoperative dietological measures * Follow-up anticipation with blood draws and body weight scans using Secca scale * Written informed consent
Exclusion criteria
* Patients with previous bariatric surgerys * Patients aged below 18 years * Patients with BMI \< 35 kg/m2 * Patients with psychiatric disorders * Patients not willing to adhere to preoperative dietological measures * Patients with contraindications against Saxenda * Patients who have health insurance other than Österreichische Gesundheitskasse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % total weight loss | body weight and bmi will be assessed immediately when admission to the study is done as reference value and at at time of operation, which is 6 months after admission to the study, as outcome value | calculation using ANCOVA, p-value ≤ 0.05 is considered statistically significant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comorbidities | The secondary parameters will be assessed immediately at the time when admission to the study is done for reference and the time of the surgery, which is 6 months after admission, as outcome parameter | The secondary parameter will be the prevalence of comorbidities (determined via use of pharmacological therapy therefore) |
| hba1c | The secondary parameters will be assessed immediately when admission to the study is done for reference and the time of the surgery, which is 6 months after admission, as outcome parameter | The secondary parameter will be hba1c in % |
| % weight lost after one year | Body weight will be assessed immediately when admission to the study is done and the time of the surgery (=6 months after admission) and 1 year post op (=18 months after admission) | % of body weight lost 1 year post op |
Contacts
Primary ContactLea Pedarnig, MD
Backup ContactMoritz Felsenreich, Ap.Prof.Priv.-Doz.DDr.
Outcome results
None listed