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Morbid ObesityPhase 4NCT02616003

Preoperative Condition in Giant Obese Patients

A Phase 4 study testing Liraglutide, Aminosteril hepa 8% and Caloric diet with 1000 kcal in people with Morbid Obesity and Bariatric Surgery Candidate, run by Sana Klinikum Offenbach at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Morbid Obesity, Bariatric Surgery Candidate
What is being tested?
Liraglutide, Aminosteril hepa 8% and Caloric diet with 1000 kcal
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteGermany
Study dates
Apr 2014to Apr 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • multimorbid, super-super obese patients

Who cannot join

  • renal insufficiency III

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Sana Klinikum Offenbach

    Offenbach, Hesse, 63069

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Liraglutide, Aminosteril hepa 8%, Caloric diet with 1000 kcal
Keywords
Morbid Obesity, Giant Obese, Preoperative Procedure, Liraglutide, Leucine
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Also called Victoza

    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)

  • 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 kcalDietary 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)

Study groups in NCT02616003
Study groupRoleWhat they receive
Super-super Obese PatientsOtherMultimorbid, 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.
Receives: Drug: Liraglutide; Other: Aminosteril hepa 8%; Dietary Supplement: Caloric diet with 1000 kcal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operability

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

    Measured: 21 days

Secondary outcomes (9)

  1. Chronic inflammation

    Changing in CRP in g/l during intervention

    Measured: 21 days

  2. Chronic inflammation II

    Changing in white blood cell count /nl during intervention

    Measured: 21 days

  3. Liver volume

    Changing of liver volume during intervention measured by ultrasound

    Measured: 21 days

  4. Liver function

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

    Measured: 21 days

  5. Pulmonary function

    Changing in FEV1 in lung function testing during intervention

    Measured: 21 days

  6. Hg A1c in %

    Measured: 21 days

  7. Total Protein in g/l

    Measured: 21 days

  8. Preoperative excess weight loss in %

    Measured: 21 days

  9. Albumin in g/l

    Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionJan 2018
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02616003
Sponsor's protocol ID
FF 121/2015
Status last verified
Mar 2021
First submitted
17 Nov 2015
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
No

Publications

  • Baggio 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.

    PubMed 25202976

  • Alhadeff 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.

    PubMed 24681814

  • Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.

    PubMed 26132939

  • Pedroso 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.

    PubMed 26007339

  • Zhang 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.

    PubMed 17360978

  • McAllan 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.

    PubMed 22535285

  • Stier C, Koschker AC, Kim M, Stier R, Chiappetta S, Stein J. 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. Clin Nutr ESPEN. 2022 Aug;50:238-246. doi: 10.1016/j.clnesp.2022.05.009. Epub 2022 May 26.

    PubMed 35871930

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide, Aminosteril hepa 8% and Caloric diet with 1000 kcal in people with Morbid Obesity and Bariatric Surgery Candidate, run by Sana Klinikum Offenbach at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operability (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02616003, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.

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