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Preoperative Condition in Giant Obese Patients

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ClinicalTrials.gov Identifier: NCT02616003
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Christine Stier, Sana Klinikum Offenbach

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Bariatric Surgery Candidate Drug: Liraglutide Other: Aminosteril hepa 8% Dietary Supplement: Caloric diet with 800 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 800 kcal/d.

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Study Type : Interventional  (Clinical Trial)
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 : August 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
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: 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 Name: 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 800 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 800 kcal from day 1 onwards till technical operability is achieved (about 21 days)




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI above 65 kg/m2

Exclusion Criteria:

  • renal insufficiency III

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616003


Locations
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Germany
Sana Klinikum Offenbach
Offenbach, Hessen, Germany, 63069
Sponsors and Collaborators
Sana Klinikum Offenbach
Investigators
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Study Chair: Rudolf Weiner, MD, Prof. Sana Klinikum Offenbach
Publications of Results:
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Responsible Party: Christine Stier, MD, PhD, Sana Klinikum Offenbach
ClinicalTrials.gov Identifier: NCT02616003    
Other Study ID Numbers: FF 121/2015
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Keywords provided by Christine Stier, Sana Klinikum Offenbach:
Morbid Obesity
Giant Obese
Preoperative Procedure
Liraglutide
Leucine
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists