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

NCT05128318 | Terminated

• 1 other identifier: TuLip
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Cachexia; Adipose Tissue

Outcome Measures

Primary Outcomes (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 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.

  Up to 100 days after the adipose tissue collection"

• 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.

  Up to 100 days after the adipose tissue collection"

Secondary Outcomes (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 western-blot

  Up to 2 years after the adipose tissue collection

• 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

  Up to 2 years after the adipose tissue collection

• 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

  Up to 2 years after the adipose tissue collection

• 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

  Up to 2 years after the adipose tissue collection

• 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

  Up to 2 years after the adipose tissue collection

Study Arms (1)

Patients with BMI < 30 kg/m2

EXPERIMENTAL

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

Procedure: Nissen Fundoplication, cholecystectomy

Interventions

Nissen Fundoplication, cholecystectomy PROCEDURE

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.

Patients with BMI < 30 kg/m2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

Study Sites (1)

Cliniques universitaires Saint Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• 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.

  PMID: 38570069 RESULT

MeSH Terms

Conditions

Neoplasms; Cachexia

Interventions

Fundoplication; Cholecystectomy

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Biliary Tract Surgical Procedures

Study Officials

• Benoit Navez, Professor

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Collection of subcutaneous and visceral adipose tissue from patients with BMI \< 30 kg/m2

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 22, 2021
• Study Start: November 16, 2022
• Primary Completion: July 18, 2023
• Study Completion: April 22, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)