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

Medical University of Vienna

Status and phase: Not yet enrolling; Phase 4

Conditions: Obesity, Adolescent

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06865365

2493/2024

Details and patient eligibility

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Group A - Control Group with only dietological measures

Active Comparator group

Description:

Patients seeking bariatricsurgery will recieve the standard dietological measures to prepare for bariatric surgery for 6 months

Treatment:

Behavioral: Dietologic measures and lifestyle optimization for weight loss

Group B - Intervention with additional Liraglutide

Experimental group

Description:

Patients seeking bariatricsurgery will recieve the standard dietological measures and additional Liraglutide to prepare for bariatric surgery for 6 months

Treatment:

Drug: Liraglutide daily (0.6-3.0mg, highest tolerable dose) additional to dietological measures and lifestyle optimization suggestions