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

NCT ID: NCT06865365

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2028-02-01

Brief Summary

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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

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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.

Conditions

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Obesity, Adolescent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial, open
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking Description

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Dietologic measures and lifestyle optimization for weight loss

Intervention Type BEHAVIORAL

all subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively.

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Liraglutide daily (0.6-3.0mg, highest tolerable dose) as additional preoperative method for weight loss

Interventions

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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

Intervention Type DRUG

Dietologic measures and lifestyle optimization for weight loss

all subjects will receive dietary measures and lifestyle opitmization suggestions in order to drop weight preoperatively.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Daniel Moritz Felsenreich

Professor (Ap. Prof. Priv. Doz. DDr. )

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Lea Pedarnig, MD

Role: CONTACT

0043014040056210

Moritz Felsenreich, Ap.Prof.Priv.-Doz.DDr.

Role: CONTACT

0043014040056210

Other Identifiers

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2493/2024

Identifier Type: -

Identifier Source: org_study_id

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