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

ConditionObesity, Adolescent
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with previous bariatric surgerys

Patients aged below 18 years

Patients with BMI < 35 kg/m2

Patients with psychiatric disorders

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

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

  • Dietologic measures and lifestyle optimization for weight loss

    Behavioral

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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Group A - Control Group with only dietological measuresActive comparator 1 intervention
Group B: Group B - Intervention with additional LiraglutideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

% total weight loss

calculation using ANCOVA, p-value ≤ 0.05 is considered statistically significant

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

Secondary outcomes

1

comorbidities

The secondary parameter will be the prevalence of comorbidities (determined via use of pharmacological therapy therefore)

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
2

hba1c

The secondary parameter will be hba1c in %

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
3

% weight lost after one year

% of body weight lost 1 year post op

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: