Bariatric Surgery Candidate, Morbid Obesity
Conditions
Keywords
Morbid Obesity, Giant Obese, Preoperative Procedure, Liraglutide, Leucine
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.
Interventions
DRUGLiraglutide
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)
OTHERAminosteril hepa 8%
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)
DIETARY_SUPPLEMENTCaloric diet with 1000 kcal
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)
Sponsors
Sana Klinikum Offenbach
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* multimorbid, super-super obese patients
Exclusion criteria
* renal insufficiency III
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operability | 21 days | Operability means that weight loss surgery could be performed after preoperative condition (due to less visceral fat, less liver volume) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Chronic inflammation | 21 days | Changing in CRP in g/l during intervention |
| Total Protein in g/l | 21 days | — |
| Preoperative excess weight loss in % | 21 days | — |
| Albumin in g/l | 21 days | — |
| Hg A1c in % | 21 days | — |
Countries
Germany
Outcome results
None listed