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

March 18, 2025 updated by: Daniel Moritz Felsenreich, Medical University of Vienna

Prospective, Randomized, Controlled Trial of Preoperative Use of Saxenda (Liraglutide) Additionally to Common Dietological Measures as Opposed to Dietological Measures Alone

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A - Control Group with only dietological measures
Patients seeking bariatricsurgery will recieve the standard dietological measures to prepare for bariatric surgery for 6 months
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.
Experimental: Group B - Intervention with additional Liraglutide
Patients seeking bariatricsurgery will recieve the standard dietological measures and additional Liraglutide to prepare for bariatric surgery for 6 months
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% 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
calculation using ANCOVA, p-value ≤ 0.05 is considered statistically significant
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

Outcome Measure
Measure Description
Time Frame
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
The secondary parameter will be the prevalence of comorbidities (determined via use of pharmacological therapy therefore)
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
The secondary parameter will be hba1c in %
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)
% of body weight lost 1 year post op
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2493/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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