Preoperative Condition in Giant Obese Patients
- Conditions
- Bariatric Surgery CandidateMorbid Obesity
- Interventions
- Registration Number
- NCT02616003
- Lead Sponsor
- Sana Klinikum Offenbach
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- multimorbid, super-super obese patients
- renal insufficiency III
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Super-super Obese Patients Caloric diet with 1000 kcal 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. Super-super Obese Patients Aminosteril hepa 8% 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. Super-super Obese Patients Liraglutide 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.
- Primary Outcome Measures
Name Time Method Operability 21 days Operability means that weight loss surgery could be performed after preoperative condition (due to less visceral fat, less liver volume)
- Secondary Outcome Measures
Name Time Method Total Protein in g/l 21 days Albumin in g/l 21 days Chronic inflammation 21 days Changing in CRP in g/l during intervention
Chronic inflammation II 21 days Changing in white blood cell count /nl during intervention
Liver volume 21 days Changing of liver volume during intervention measured by ultrasound
Liver function 21 days Changing of GOT in U/l, GPT in U/l, GGT in U/l and AP in U/l
Pulmonary function 21 days Changing in FEV1 in lung function testing during intervention
Hg A1c in % 21 days Preoperative excess weight loss in % 21 days
Trial Locations
- Locations (1)
Sana Klinikum Offenbach
🇩🇪Offenbach, Hessen, Germany