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

Phase 4

Not yet recruiting

• Conditions: Obesity, Adolescent
• Interventions: Behavioral: Dietologic measures and lifestyle optimization for weight loss; Drug: Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions

• Registration Number: NCT06865365
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2025-01-23
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-07
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Study Start: 2025-05-01
• Primary Completion: 2027-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - Control Group with only dietological measures	Dietologic measures and lifestyle optimization for weight loss	Patients seeking bariatricsurgery will recieve the standard dietological measures to prepare for bariatric surgery for 6 months
Group B - Intervention with additional Liraglutide	Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions	Patients seeking bariatricsurgery will recieve the standard dietological measures and additional Liraglutide to prepare for bariatric surgery for 6 months

Primary Outcome Measures

Name	Time	Method
% 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 Outcome Measures

Name	Time	Method
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
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)