Preoperative Condition in Giant Obese Patients

Sana Klinikum Offenbach

Status and phase: Completed; Phase 4

Conditions: Bariatric Surgery Candidate; Morbid Obesity

Treatments: Dietary Supplement: Caloric diet with 1000 kcal; Drug: Liraglutide; Other: Aminosteril hepa 8%

Study type: Interventional

Funder types: Other

Identifiers

NCT02616003

FF 121/2015

Details and patient eligibility

About

The frequency of super-super obese who need immediate weight loss surgery is risen continuously. For those patients a prior-to-surgery conditioning therapy is mandatory to gain technical and physical operability. The exclusively well-established preliminary therapy so far was the intragastric balloon, which takes 7 months of treatment time. Due to life-threatening conditions of giant obese patients, who have been admitted to hospital, the investigators were forced to develop a more prompt acting conditioning therapy to bring those individuals in a short run to an improved and "fit-for-surgery" state. In such an impasse the investigators combine Liraglutide with its well-known weight-loss effect with a leucine-based amino acid infusion that is generally used for patients with liver insufficiency, in expectance of an additional weight loss and liver reduction effect.

Full description

The investigators will use a commercial available amino acid infusion (Aminosteril hepa 8%, Fresenius Karbi), which is used in clinical application for liver conditioning. It is mainly based on the branched-chained amino acid leucine (13.09 g per 1000 ml). The investigators will combine this with a daily subcutaneous injection of Liraglutide. Liraglutide is a GLP-1 analogue, which achieved meanwhile the FDA approval for weight loss treatment. Initial Liraglutide dosage is 1.2 mg for three days, boosted to 1.8 mg consecutively. Participants receive energy reduced nutrition with 1000 kcal/d.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• multimorbid, super-super obese patients

Exclusion criteria

• renal insufficiency III

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Super-super Obese Patients

Other group

Description:

Multimorbid, super-super obese patients that need preoperative conditioning therapy (intervention 1: Liraglutide, intervention 2: aminosteril hepa 8%, intervention 3: Caloric diet with 1000 kcal) for weight loss surgery to achieve technical operability.

Treatment:

Dietary Supplement: Caloric diet with 1000 kcal

Drug: Liraglutide

Other: Aminosteril hepa 8%