Current partner codePEPTIDESDE
NCT06865365·Phase 4·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Phase 4

Enrollment

72

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 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.

Interventions

Treatment arms and agents.

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

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.

Timeline

From registration to results.

  1. First posted

    Mar 7, 2025

  2. Study start

    May 1, 2025

  3. Primary completion

    Feb 1, 2027

  4. Study completion

    Feb 1, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Mar 21, 2025

Outcomes

What the study measures.

Primary outcomes

% 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

Secondary outcomes

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)

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 %

% 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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Liraglutide.

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