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Completed

NCT Number: NCT02616003

Preoperative Condition in Giant Obese Patients

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.

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Key information

Conditions

Morbid Obesity Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sana Klinikum Offenbach

Offenbach, Hesse, 63069, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • multimorbid, super-super obese patients

Exclusion criteria

  • renal insufficiency III

Treatment and study plan

liraglutide

Drug

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)

Other names: Victoza

Aminosteril hepa 8%

Other

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)

Caloric diet with 1000 kcal

Dietary Supplement

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)

Primary outcomes

  1. Operability

    Time frame: 21 days

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

Secondary outcomes

  1. Chronic inflammation

    Time frame: 21 days

    Changing in CRP in g/l during intervention

  2. Chronic inflammation II

    Time frame: 21 days

    Changing in white blood cell count /nl during intervention

  3. Liver volume

    Time frame: 21 days

    Changing of liver volume during intervention measured by ultrasound

  4. Liver function

    Time frame: 21 days

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

  5. Pulmonary function

    Time frame: 21 days

    Changing in FEV1 in lung function testing during intervention

  6. Hg A1c in %

    Time frame: 21 days

  7. Total Protein in g/l

    Time frame: 21 days

  8. Preoperative excess weight loss in %

    Time frame: 21 days

  9. Albumin in g/l

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Sana Klinikum Offenbach

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2015
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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