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Preoperative Condition in Giant Obese Patients

Sponsor
Sana Klinikum Offenbach (Other)
Overall Status
Completed
CT.gov ID
NCT02616003
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
48
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Liraglutide
  • Other: Aminosteril hepa 8%
  • Dietary Supplement: Caloric diet with 1000 kcal
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Super-super Obese Patients

Multimorbid, super-super obese patients that need preoperative conditioning therapy (intervention 1: Liraglutide, intervention 2: aminosteril hepa 8%, intervention 3: Caloric diet with 1000 kcal) for weight loss surgery to achieve technical operability.

Drug: Liraglutide
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

    • Other: Aminosteril 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 Supplement: Caloric 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)

    Outcome Measures

    Primary Outcome Measures

    1. Operability [21 days]

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

    Secondary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • multimorbid, super-super obese patients
    Exclusion Criteria:
    • renal insufficiency III

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sana Klinikum Offenbach Offenbach Hessen Germany 63069

    Sponsors and Collaborators

    • Sana Klinikum Offenbach

    Investigators

    • Study Chair: Rudolf Weiner, MD, Prof., Sana Klinikum Offenbach

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christine Stier, MD, PhD, Sana Klinikum Offenbach
    ClinicalTrials.gov Identifier:
    NCT02616003
    Other Study ID Numbers:
    • FF 121/2015
    First Posted:
    Nov 26, 2015
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by Christine Stier, MD, PhD, Sana Klinikum Offenbach
    Morbid Obesity
    Giant Obese
    Preoperative Procedure
    Liraglutide
    Leucine
    Additional relevant MeSH terms:
    Obesity, Morbid
    Liraglutide

    Study Results

    No Results Posted as of Mar 23, 2021