Clinical trial NCT02616003: Preoperative Condition in Giant Obese Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Morbid Obesity
Bariatric Surgery Candidate
Keywords: Morbid Obesity
Giant Obese
Preoperative Procedure
Liraglutide
Leucine
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* multimorbid, super-super obese patients

Exclusion Criteria:

* renal insufficiency III

Primary outcomes:
measure: Operability
timeFrame: 21 days
Secondary outcomes:
measure: Chronic inflammation
timeFrame: 21 days
measure: Chronic inflammation II
timeFrame: 21 days
measure: Liver volume
timeFrame: 21 days
measure: Liver function
timeFrame: 21 days
measure: Pulmonary function
timeFrame: 21 days
measure: Hg A1c in %
timeFrame: 21 days
measure: Total Protein in g/l
timeFrame: 21 days
measure: Preoperative excess weight loss in %
timeFrame: 21 days
measure: Albumin in g/l
timeFrame: 21 days
Other outcomes:
Locations:
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
state: Hessen
Study officials:
affiliation: Sana Klinikum Offenbach
name: Rudolf Weiner, MD, Prof.
role: STUDY_CHAIR
References:
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citation: Stier C, Koschker AC, Kim M, Stier R, Chiappetta S, Stein J. Fast-track rescue weight reduction therapy to achieve rapid technical operability for emergency bariatric surgery in patients with life-threatening inoperable severe obesity - A proof of concept study. Clin Nutr ESPEN. 2022 Aug;50:238-246. doi: 10.1016/j.clnesp.2022.05.009. Epub 2022 May 26.