NCT01655017: fibrota

Fibrosis a New Pathological Actor in Adipose Tissue

Completed NA Last updated 13 November 2020

What this trial tests

NA trial testing biopsy in Obesity in 281 participants. Completed in 6 April 2018.

Timeline

8 February 2012

Primary endpoint
6 April 2018

6 April 2018

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	281
Start date	8 February 2012
Primary completion	6 April 2018
Estimated completion	6 April 2018
Sites	2 locations across France

Drugs / interventions tested

• biopsy — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →
• Metabolic Diseases — all drugs for Metabolic Diseases →
• Fibrosis — all drugs for Fibrosis →
• Body Weight — all drugs for Body Weight →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 65, any sex, with Obesity or Metabolic Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on adipose biopsies appears to to predict weight loss response after a bariatric surgery. Non invasive tools to measure fibrosis needs to be validated. The investigators primary aim is to validate a new device able to measure adipose tissue stiffness.

Thus the investigators plan to compare the stiffness results obtained with the device to the quantification of fibrosis using immuno-chemistry in massively obese patient's candidates to a bariatric surgery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impairment of gut microbial biotin metabolism and host biotin status in severe obesity: effect of biotin and prebiotic supplementation on improved metabolism.
   Belda E, Voland L, Tremaroli V, Falony G, et al · · 2022 · cited 103× · PMID 35017197 · DOI 10.1136/gutjnl-2021-325753
2. Immune cell-derived cytokines contribute to obesity-related inflammation, fibrogenesis and metabolic deregulation in human adipose tissue.
   Caër C, Rouault C, Le Roy T, Poitou C, et al · · 2017 · cited 101× · PMID 28592801 · DOI 10.1038/s41598-017-02660-w
3. Hepatic stellate cell hypertrophy is associated with metabolic liver fibrosis.
   Hoffmann C, Djerir NEH, Danckaert A, Fernandes J, et al · · 2020 · cited 50× · PMID 32123215 · DOI 10.1038/s41598-020-60615-0
4. Dysregulation of macrophage PEPD in obesity determines adipose tissue fibro-inflammation and insulin resistance.
   Pellegrinelli V, Rodriguez-Cuenca S, Rouault C, Figueroa-Juarez E, et al · · 2022 · cited 39× · PMID 35478031 · DOI 10.1038/s42255-022-00561-5
5. The human gut microbiota contributes to type-2 diabetes non-resolution 5-years after Roux-en-Y gastric bypass.
   Debédat J, Le Roy T, Voland L, Belda E, et al · · 2022 · cited 27× · PMID 35435140 · DOI 10.1080/19490976.2022.2050635
6. Regulation of Cellular Senescence in Type 2 Diabetes Mellitus: From Mechanisms to Clinical Applications.
   Iwasaki K, Abarca C, Aguayo-Mazzucato C. · · 2023 · cited 24× · PMID 36872059 · DOI 10.4093/dmj.2022.0416
7. Obesity Due to Steroid Receptor Coactivator-1 Deficiency Is Associated With Endocrine and Metabolic Abnormalities.
   Cacciottolo TM, Henning E, Keogh JM, Bel Lassen P, et al · · 2022 · cited 17× · PMID 35137184 · DOI 10.1210/clinem/dgac067
8. 53 <sup>rd</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Lisbon, Portugal, 11 - 15 September 2017.
   · 2017 · cited 17× · PMID 28795195 · DOI 10.1007/s00125-017-4350-z