Cancer Clinical Trial
— TuLipOfficial title:
Study of the Tumor-adipose Tissue Dialogue: Role of Tumor Acidosis in the Induction of Adipocyte Lipolysis
NCT number | NCT05128318 |
Other study ID # | TuLip |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | November 16, 2022 |
Est. completion date | April 22, 2024 |
Verified date | May 2024 |
Source | Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | April 22, 2024 |
Est. primary completion date | July 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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: - 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques universitaires Saint Luc | Brussel |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
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. Ep — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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" | |
Primary | 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 | 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). | Up to 2 years after the adipose tissue collection | |
Secondary | 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). | Up to 2 years after the adipose tissue collection | |
Secondary | 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). | Up to 2 years after the adipose tissue collection | |
Secondary | 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) | Up to 2 years after the adipose tissue collection | |
Secondary | 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) | Up to 2 years after the adipose tissue collection | |
Secondary | 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. | Up to 2 years after the adipose tissue collection | |
Secondary | 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. | Up to 2 years after the adipose tissue collection |
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