NCT02616003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

3.8 years

First QC Date

November 17, 2015

Last Update Submit

March 21, 2021

Conditions

Morbid ObesityBariatric Surgery Candidate

Keywords

Morbid ObesityGiant ObesePreoperative ProcedureLiraglutideLeucine

Outcome Measures

Primary Outcomes (1)

  • Operability

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

    21 days

Secondary Outcomes (9)

  • Chronic inflammation

    21 days

  • Chronic inflammation II

    21 days

  • Liver volume

    21 days

  • Liver function

    21 days

  • Pulmonary function

    21 days

  • +4 more secondary outcomes

Study Arms (1)

Super-super Obese Patients

OTHER

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: LiraglutideOther: Aminosteril hepa 8%Dietary Supplement: Caloric diet with 1000 kcal

Interventions

LiraglutideDRUG

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)

Also known as: Victoza
Super-super Obese Patients
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)

Super-super Obese Patients
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)

Super-super Obese Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • multimorbid, super-super obese patients

You may not qualify if:

  • renal insufficiency III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sana Klinikum Offenbach

Offenbach, Hesse, 63069, Germany

Location

Related Publications (7)

  • 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.

    PMID: 25202976RESULT

  • 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.

    PMID: 24681814RESULT

  • 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.

    PMID: 26132939RESULT

  • 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.

    PMID: 26007339RESULT

  • 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.

    PMID: 17360978RESULT

  • 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.

    PMID: 22535285RESULT

  • 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.

    PMID: 35871930DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Rudolf Weiner, MD, Prof.

    Sana Klinikum Offenbach

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 26, 2015

Study Start

April 1, 2014

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

DE(1)