Preoperative Condition in Giant Obese Patients

Morbid Obesity Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Morbid Obesity
• Obesity, Morbid

• NCT number: NCT02616003
• Study type: Interventional
• Source: Sana Klinikum Offenbach
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Completion date: April 2018