Clinical trial

Preoperative Use of Liraglutide Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone

Opening soon · Phase 4 · 0 countries · Registry ID NCT06865365

Opening soonPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Adolescent

Full registry 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

Treatments and study arms

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

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.

Primary outcomes

% total weight lossbody 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

Study locations

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No public site location was included in this record. Check the original registry for updates.