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Trial · Interventional

CompletedPhase 4Registry data

Preoperative Condition in Giant Obese Patients

NCTNCT02616003 (opens ClinicalTrials.gov in a new tab)Other idFF 121/2015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
50 participants (actual)
Sponsor
Sana Klinikum Offenbach · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Germany

Start
Apr 2014
Primary completion
Jan 2018
Completion
Apr 2018
First posted
26 Nov 2015 (estimated)
Last update posted
23 Mar 2021
Conditions
Morbid Obesity · Bariatric Surgery Candidate

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016201720182019
  1. Ph 4

    Preoperative Condition in Giant Obese Patients

    NCT02616003

    Apr 2014 to Apr 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • Aminosteril hepa 8%Other
  • Caloric diet with 1000 kcalDietary supplement

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Operability

    Time frame · 21 days

    Registry description

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

Secondary outcomes(9)

  1. Chronic inflammation

    Time frame · 21 days

    Registry description

    Changing in CRP in g/l during intervention

  2. Chronic inflammation II

    Time frame · 21 days

    Registry description

    Changing in white blood cell count /nl during intervention

  3. Liver volume

    Time frame · 21 days

    Registry description

    Changing of liver volume during intervention measured by ultrasound

  4. Liver function

    Time frame · 21 days

    Registry description

    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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Clinical trial · 2022

3 results

Fast-track rescue weight reduction therapy to achieve rapid technical operability for emergency bariatric surgery in patients with life-threatening inoperable severe obesity - A proof of concept study.

Stier et al. 2022Clinical nutrition ESPENcited by 11

PMID 35871930DOI 10.1016/j.clnesp.2022.05.009PUB-35871930

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2015

6 results

A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.

Pi-Sunyer et al. 2015The New England journal of medicinecited by 1,954

PMID 26132939DOI 10.1056/nejmoa1411892PUB-26132939

Rights unknown6 results
Source linkSee results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultBaggio LL, Drucker DJ. Glucagon-like peptide-1 receptors in the brain: controlling food intake and body weight. J Clin Invest. 2014 Oct;124(10):4223-6. doi: 10.1172/JCI78371. Epub 2014 Sep 9. PMID 25202976
  • ResultAlhadeff AL, Baird JP, Swick JC, Hayes MR, Grill HJ. Glucagon-like Peptide-1 receptor signaling in the lateral parabrachial nucleus contributes to the control of food intake and motivation to feed. Neuropsychopharmacology. 2014 Aug;39(9):2233-43. doi: 10.1038/npp.2014.74. Epub 2014 Mar 26. PMID 24681814
  • ResultPedroso JA, Zampieri TT, Donato J Jr. Reviewing the Effects of L-Leucine Supplementation in the Regulation of Food Intake, Energy Balance, and Glucose Homeostasis. Nutrients. 2015 May 22;7(5):3914-37. doi: 10.3390/nu7053914. PMID 26007339
  • ResultZhang Y, Guo K, LeBlanc RE, Loh D, Schwartz GJ, Yu YH. Increasing dietary leucine intake reduces diet-induced obesity and improves glucose and cholesterol metabolism in mice via multimechanisms. Diabetes. 2007 Jun;56(6):1647-54. doi: 10.2337/db07-0123. Epub 2007 Mar 14. PMID 17360978
  • ResultMcAllan L, Cotter PD, Roche HM, Korpela R, Nilaweera KN. Impact of leucine on energy balance. J Physiol Biochem. 2013 Mar;69(1):155-63. doi: 10.1007/s13105-012-0170-2. Epub 2012 Apr 26. PMID 22535285

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * multimorbid, super-super obese patients Exclusion Criteria: * renal insufficiency III

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