Preoperative Condition in Giant Obese Patients

March 21, 2021 updated by: Christine Stier, Sana Klinikum Offenbach

A Novel Preoperative Conditioning Therapy in Giant Obese Patients With the Combination of Liraglutide and a Leucine-Based Amino-Acid Infusion and Caloric Restriction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Offenbach, Hessen, Germany, 63069
        • Sana Klinikum Offenbach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • multimorbid, super-super obese patients

Exclusion Criteria:

  • renal insufficiency III

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic inflammation
Time Frame: 21 days
Changing in CRP in g/l during intervention
21 days
Chronic inflammation II
Time Frame: 21 days
Changing in white blood cell count /nl during intervention
21 days
Liver volume
Time Frame: 21 days
Changing of liver volume during intervention measured by ultrasound
21 days
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
21 days
Pulmonary function
Time Frame: 21 days
Changing in FEV1 in lung function testing during intervention
21 days
Hg A1c in %
Time Frame: 21 days
21 days
Total Protein in g/l
Time Frame: 21 days
21 days
Preoperative excess weight loss in %
Time Frame: 21 days
21 days
Albumin in g/l
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana Klinikum Offenbach

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF 121/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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