Preoperative Condition in Giant Obese Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Novel Preoperative Conditioning Therapy in Giant Obese Patients With the Combination of Liraglutide and a Leucine-Based Amino-Acid Infusion and Caloric Restriction

Conditions
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Morbid Obesity, Bariatric Surgery Candidate

Intervention / Treatment
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* Drug: Liraglutide
* Other: Aminosteril hepa 8%
* Dietary Supplement: Caloric diet with 1000 kcal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: multimorbid, super-super obese patients Exclusion Criteria: renal insufficiency III
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Super-super Obese Patients<br>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. | Drug: Liraglutide<br>* Initially 1.2 mg Liraglutide as subcutaneous daily injection, boosted to 1.8 mg Liraglutide after 3 days subsequently. 1000 ml infusion of aminosteril hepa 8% from day 1 onwards. Caloric diet with 800 kcal from day 1 onwards till technical operability is achieved (about 21 days)<br>* Other names: Victoza;Other: Aminosteril hepa 8%<br>* Initially 1.2 mg Liraglutide as subcutaneous daily injection, boosted to 1.8 mg Liraglutide after 3 days subsequently. 1000 ml infusion of aminosteril hepa 8% from day 1 onwards. Caloric diet with 800 kcal from day 1 onwards till technical operability is achieved (about 21 days)<br>Dietary Supplement: Caloric diet with 1000 kcal<br>* Initially 1.2 mg Liraglutide as subcutaneous daily injection, boosted to 1.8 mg Liraglutide after 3 days subsequently. 1000 ml infusion of aminosteril hepa 8% from day 1 onwards. Caloric diet with 1000 kcal from day 1 onwards till technical operability is achieved (about 21 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operability | Operability means that weight loss surgery could be performed after preoperative condition (due to less visceral fat, less liver volume) | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic inflammation | Changing in CRP in g/l during intervention | 21 days | 
| Chronic inflammation II | Changing in white blood cell count /nl during intervention | 21 days | 
| Liver volume | Changing of liver volume during intervention measured by ultrasound | 21 days | 
| Liver function | Changing of GOT in U/l, GPT in U/l, GGT in U/l and AP in U/l | 21 days | 
| Pulmonary function | Changing in FEV1 in lung function testing during intervention | 21 days | 
| Hg A1c in % |  | 21 days | 
| Total Protein in g/l |  | 21 days | 
| Preoperative excess weight loss in % |  | 21 days | 
| Albumin in g/l |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid Obesity, Giant Obese, Preoperative Procedure, Liraglutide, Leucine