Preoperative Condition in Giant Obese Patients

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Sana Klinikum Offenbach

临床试验: NCT02616003

BioSeek: nct02616003

关键词

抽象

The frequency of patients with a BMI above 70 kg/m2 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.

描述

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 800 kcal/d.

日期

最后验证:	03/31/2018
首次提交:	11/16/2015
提交的预估入学人数:	11/23/2015
首次发布:	11/25/2015
上次提交的更新:	04/23/2018
最近更新发布:	04/25/2018
实际学习开始日期:	07/31/2015
预计主要完成日期:	12/31/2017
预计完成日期:	03/31/2018

状况或疾病

Morbid Obesity

Bariatric Surgery Candidate

干预/治疗

Drug: Giant Obese Patients (BMI >65 kg/m2)

Other: Giant Obese Patients (BMI >65 kg/m2)

Dietary Supplement: Giant Obese Patients (BMI >65 kg/m2)

相

相 4

手臂组

臂	干预/治疗
Other: Giant Obese Patients (BMI >65 kg/m2) Patients with a BMI above 65 kg/m2 that need preoperative conditioning therapy (intervention 1: Liraglutide, intervention 2: aminosteril hepa 8%, intervention 3: Caloric diet with 800 kcal) for weight loss surgery to achieve technical operability.	Drug: Giant Obese Patients (BMI >65 kg/m2) 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)

资格标准

有资格学习的性别

All

接受健康志愿者

是

标准

Inclusion Criteria:

- BMI above 65 kg/m2

Exclusion Criteria:

- renal insufficiency III

结果

主要结果指标

1. Operability [21 days]

Operability means that weight loss surgery could be performed after preoperative condition (due to less visceral fat, less liver volume)

次要成果指标

1. Chronic inflammation [21 days]

Changing in CRP in g/l during intervention

2. Chronic inflammation II [21 days]

Changing in white blood cell count /nl during intervention

3. Liver volume [21 days]

Changing of liver volume during intervention measured by ultrasound

4. Liver function [21 days]

Changing of GOT in U/l, GPT in U/l, GGT in U/l and AP in U/l

5. Pulmonary function [21 days]

Changing in FEV1 in lung function testing during intervention

6. Hg A1c in % [21 days]

7. Total Protein in g/l [21 days]

8. Preoperative excess weight loss in % [21 days]

9. Albumin in g/l [21 days]

Preoperative Condition in Giant Obese Patients

关键词

obesity

减肥

抽象

描述

日期

状况或疾病

干预/治疗

相

手臂组

资格标准

结果

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