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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Control Group with only dietological measures | Active Comparator | Patients seeking bariatricsurgery will recieve the standard dietological measures to prepare for bariatric surgery for 6 months |
|
| Group B - Intervention with additional Liraglutide | Experimental | Patients seeking bariatricsurgery will recieve the standard dietological measures and additional Liraglutide to prepare for bariatric surgery for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions | Drug | Liraglutide daily (0.6-3.0mg, highest tolerable dose) as additional preoperative method for weight loss |
| Measure | Description | Time Frame |
|---|---|---|
| % total weight loss | calculation using ANCOVA, p-value ≤ 0.05 is considered statistically significant | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| comorbidities | The secondary parameter will be the prevalence of comorbidities (determined via use of pharmacological therapy therefore) | 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 |
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Inclusion Criteria:
- Patients seeking bariatric surgery
Exclusion Criteria:
Patients with previous bariatric surgerys
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lea Pedarnig, MD | Contact | 0043014040056210 | lea.pedarnig@meduniwien.ac.at | |
| Moritz Felsenreich, Ap.Prof.Priv.-Doz.DDr. | Contact | 0043014040056210 | moritz.felsenreich@meduniwien.ac.at |
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Randomized controlled trial, open
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Masking Description
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| Dietologic measures and lifestyle optimization for weight loss | Behavioral | all subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively. |
|
| hba1c |
The secondary parameter will be hba1c in % |
| 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 |
| % weight lost after one year | % of body weight lost 1 year post op | 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) |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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