Preoperative Use of Liraglutide Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions, Dietologic measures and lifestyle optimization for weight loss.
- Who it may be relevant to
- Registry conditions: Obesity, Adolescent. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Randomized, Controlled Trial of Preoperative Use of Saxenda (Liraglutide) Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
Overview
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
- Drug Liraglutide 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 - Behavioral Dietologic measures and lifestyle optimization for weight loss
all subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively.
Primary outcome measures
- % total weight loss [Time frame: 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 outcome measures (3)
- comorbidities [Time frame: 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]
- hba1c [Time frame: 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 [Time frame: 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06865365 · 2493/2024