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NCT03027479 Clinical Trial

Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss

Weight Loss Clinical Trial

— METERMUS-IMC  

Official title:
Study of Differences in Skeletal Muscle Energy Metabolism Alterations in Women With Weight Loss and Ovarian and/or Endometrial Cancer Based on the Body Mass Index

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03027479
Other study ID # PHAO16-LO/METERMUS-IMC
Secondary ID 2016-A01323-4820
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date July 16, 2019

Study information
Verified date May 2021
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim is to study skeletal muscle metabolism alterations métaboliques associated with weight loss in women with ovarian and/or endometrial cancer according to BMI.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date July 16, 2019
Est. primary completion date July 16, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Case group selection criteria: Inclusion Criteria: - Women aged 18 years old and more - Ovarian and/or endometrial cancer - weight loss related to cancer (weight loss > 5% weight in one month or 10% in 6 months) - Indication to therapeutic surgery - Women affiliated to social security scheme - Women who can understand French and able to sign Informed consent Exclusion Criteria: - Unbalanced Diabetes - Chronic neuromuscular disorder - Any severe uncontrolled medical condition Control group selection criteria: Inclusion Criteria: - Women aged 18 years and more - Surgery Indication for a benign endometrial and/ or ovarian disease - Patient affiliated to social security scheme - Women who can understand French and able to sign Informed consent Exclusion Criteria: - Unbalanced Diabetes - Chronic neuromuscular disorder - Any severe uncontrolled medical condition

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Samples
Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample

Locations
Country Name City State
France Gynecology Department, University Teaching Hospital, Tours Tours

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Tours Inserm U1069 - Team Nutrition, Growth and Cancer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of muscle mitochondrial bioenergetics according to BMI Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy muscle biopsy realized during surgery
Secondary on muscle biopsy Quantification of lipids on electron microscope
Type of muscular fibers
Analyze of gene expression and proteins involved in 1/ Mitochondrial metabolism 2/ lipid metabolism and 3/ muscular proteolysis by RTqPCR with SyBR Green and Western Blot		 muscle biopsy realized during surgery
Secondary on white adipose tissue adipose tissue composition (fatty acids quantification, sterols, steroids)
RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profile and cytokines)
RTqPCR analysis, western blot and immunohistochemical expression of markers of transformation into brown adipose tissue
in specific milieu, in vitro experimentation on skeletal muscular cells		 adipose tissue samples taken during surgery
Secondary on ovarian cancer tumor samples lipid composition (fatty acids quantification, sterols, steroids)
RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profil and cytokines)
culture of tumour cells to evaluate resistance to chemotherapy (platinum)		 ovarian tumor biopsies realized during surgery
Secondary on computerized tomography assessment of body composition (fat and muscle compartments) 1 day of abdominal CT scan imaging procedure performed at diagnosis
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