Thinking of joining a study?

Register your interest

NCT06865365 | NOT YET RECRUITING | Obesity, Adolescent


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

Medical University of Vienna

Information provided by (Responsible Party):

Daniel Moritz Felsenreich

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.

Condition or disease

Obesity, Adolescent

Intervention/treatment

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

Phase

PHASE4

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 Type : INTERVENTIONAL
Estimated Enrollment : 72 participants
Masking : NONE
Masking Description : Masking Description
Primary Purpose : TREATMENT
Official Title : Prospective, Randomized, Controlled Trial of Preoperative Use of Saxenda (Liraglutide) Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2027-02-01
Estimated Study Completion Date : 2028-02-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT06865365


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


No Location Found

Loading...