Clinical trial NCT06865365: Preoperative Use of Liraglutide Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
Official title: Prospective, Randomized, Controlled Trial of Preoperative Use of Saxenda (Liraglutide) Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Obesity, Adolescent
Keywords: Obesity
Bariatric surgery
metabolic surgery
liraglutide
saxenda
weight loss
surgery risk reduction
excess weight loss
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, open
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: % total weight loss
timeFrame: 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
Secondary outcomes:
measure: comorbidities
timeFrame: 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
measure: hba1c
timeFrame: 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
measure: % weight lost after one year
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
References: