Preoperative Condition in Giant Obese Patients

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliImekamilika

Wadhamini

Sana Klinikum Offenbach

JARIBIO LA KLINIKI: NCT02616003

BioSeek: nct02616003

Maneno muhimu

Kikemikali

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.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho:	03/31/2018
Iliyowasilishwa Kwanza:	11/16/2015
Uandikishaji uliokadiriwa Uliwasilishwa:	11/23/2015
Iliyotumwa Kwanza:	11/25/2015
Sasisho la Mwisho Liliwasilishwa:	04/23/2018
Sasisho la Mwisho Lilichapishwa:	04/25/2018
Tarehe halisi ya kuanza kwa masomo:	07/31/2015
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	12/31/2017
Tarehe ya Kukamilisha Utafiti:	03/31/2018

Hali au ugonjwa

Morbid Obesity

Bariatric Surgery Candidate

Uingiliaji / matibabu

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)

Awamu

Awamu 4

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
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)

Vigezo vya Kustahiki

Jinsia Inastahiki Kujifunza

All

Hupokea Wajitolea wa Afya

Ndio

Vigezo

Inclusion Criteria:

- BMI above 65 kg/m2

Exclusion Criteria:

- renal insufficiency III

Matokeo

Hatua za Matokeo ya Msingi

1. Operability [21 days]

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

Hatua za Matokeo ya Sekondari

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]