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TerminatedNCT05128318TuLipUpdated May 9, 2024

TuLip : Role of the Tumor Environment in Cancer-related Fat Loss

An interventional study of Nissen Fundoplication, cholecystectomy in Cancer, Cachexia and Adipose Tissue, sponsored by Université Catholique de Louvain. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Basic science

Why this study was terminated
Limited number of recruited patients
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Cancer cachexia is defined as a weight loss of more than 5% over the last 6 months, a loss of body fat and muscle atrophy. It is found in 80% of patients with advanced cancer. In this context, white adipose tissue is a particularly interesting target since its depletion precedes the loss of muscle mass, and is sufficient to induce a decrease in the response to anti-cancer treatments and in the survival of patients.

This cachexia is associated with advanced tumors that present acidosis and metastasis. In this clinical study the investigators would like explore the acid environment effect on the human adipose tissue depletion and more specifically on adipocyte lipolysis.

The main objective of the "TuLip" clinical study is therefore to validate in human subcutaneous and visceral adipocytes that factors secreted by tumor cells cultivated in acid tumor environment stimulate the release of lipids from adipose tissue. Adipocytes retrieves from this study will also be used to validate identified potential lipolytic factors derived from these cells.

Read the detailed description

This study is a monocentric clinical study. Patients with BMI \< 30 kg/m2 will be recruited in the context of programmed abdominal surgery. In this context, subcutaneous and visceral adipose tissue pieces (1-2 cm3) will be collected to explore the lypolytic response of adipocytes ex-vivo to factors secreted by human cancer cell lines.

02

Conditions studied

  • Cancer
  • Cachexia
  • Adipose Tissue

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03

In context

Cachexia

328 studies on the registry are indexed under Cachexia; 73 are open to participants now.

This study's enrollment of 5 is below the median of 63 across 219 interventional studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 144 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Programmed surgeries in the abdominal area in the Department of Surgery and Transplantation at Cliniques Universitaires Saint-Luc under the supervision of Prof. Dr. Benoit Navez.
  • Hospitalization in the context of surgery
  • Caucasian
  • Age between 18 and 60 years (included).
  • Body mass index less than 30 and greater than or equal to 18.5
  • Programmed Nissen fundoplication (to treat hiatal hernia and gastroesophageal reflux) or cholecystectomy (to treat vesicular lithiasis), eventration, or parietal surgery .
  • Adults capable of expressing their wishes.
  • Understanding French

Exclusion criteria

Exclusion Criteria:

  • Body mass index below 18.5 and above 30.
  • Patients with cancer, infection, autoimmune or inflammatory disease, metabolic syndrome.
  • Patients with beta-blockers, hypoglycemics, anti-diabetics, hypolipidemics.
  • Adults unable to express their will.
  • Not understanding French
  • Patients participating in a clinical trial for a drug treatment.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Patients with BMI < 30 kg/m2

    Collection of subcutaneous and visceral adipose tissue pieces of 1-2 cm3 during abdominal surgery procedures

    Procedure: Nissen Fundoplication, cholecystectomy

Interventions

  • ProcedureNissen Fundoplication, cholecystectomy

    Collection of adipose tissue pieces in the context of programmed abdominal surgery to treat to treat hiatal hernia, gastroesophageal reflux or vesicular lithiasis. During the surgery treatment, adipose tissue of 1-2 cm3 will be collected for the protocol by laparoscopy by the surgeon in charge of the procedures.

06

What researchers measure

Primary outcomes

  1. Evaluation of the lipolytic response of adipocytes isolated from human visceral and subcutaneous adipose tissue to factors derived from cancer cells in acid environment by the glycerol measurement

    Measure ex-vivo of the lipolysis of subcutaneous and visceral adipocytes in the presence of factors derived from cancer cells. The lipolysis will be assessed by the measure of glycerol (in mol/L) released by adipocytes.

    Time frame: Up to 100 days after the adipose tissue collection"

  2. Evaluation of the lipolytic response of adipocytes isolated from human visceral and subcutaneous adipose tissue to factors derived from cancer cells in acid environment by the fatty acid measurement.

    Measure ex-vivo of the lipolysis of subcutaneous and visceral adipocytes in the presence of factors derived from cancer cells. The lipolysis will be assessed by the measure of free fatty acids (in mol/L) released by adipocytes.

    Time frame: Up to 100 days after the adipose tissue collection"

Secondary outcomes

  1. Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by western-blot

    Protein analyses by western-blot (arbitrary units).

    Time frame: Up to 2 years after the adipose tissue collection

  2. Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by ELISA

    Protein analyses by ELISA (mol/L or g/L).

    Time frame: Up to 2 years after the adipose tissue collection

  3. Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by proteomic analyses

    Protein analyses via proteomic analyses (relative units).

    Time frame: Up to 2 years after the adipose tissue collection

  4. Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by biochemical analyses

    Biochemical analyses (biochemical kits)

    Time frame: Up to 2 years after the adipose tissue collection

  5. Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by metabolomic analyses

    Metabolomic analyses (arbitrary units or mol/L)

    Time frame: Up to 2 years after the adipose tissue collection

  6. Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by RNA sequencing

    Measurement of gene expression by RNA sequencing (in counts) of RNA extracted from these ex-vivo cultured human adipocytes.

    Time frame: Up to 2 years after the adipose tissue collection

  7. Evaluation of the lipid metabolism, of adipocytes isolated from human visceral and subcutaneous adipose tissues to factors derived from cancer cells in acid environment, by RT-qPCR

    Measurement of gene expression by RT-qPCR (in relative units) of RNA extracted from these ex-vivo cultured human adipocytes.

    Time frame: Up to 2 years after the adipose tissue collection

07

Study locations

1 site
  • Cliniques universitaires Saint Luc
    Brussel, 1200, Belgium
08

References and documents

Publications

  • Lefevre C, Thibaut MM, Loumaye A, Thissen JP, Neyrinck AM, Navez B, Delzenne NM, Feron O, Bindels LB. Tumoral acidosis promotes adipose tissue depletion by fostering adipocyte lipolysis. Mol Metab. 2024 May;83:101930. doi: 10.1016/j.molmet.2024.101930. Epub 2024 Apr 1. PubMed 38570069 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05128318
Lead sponsor
Université Catholique de Louvain
Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Nov 22, 2021
Start date
Nov 16, 2022
Primary completion
Jul 18, 2023
Completion
Apr 22, 2024
Last update
May 9, 2024

Study contacts

Benoit Navez, Professor
principal investigator · Cliniques universitaires Saint-Luc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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