Collection of Human Metabolic Tissues
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity Hospital, Montpellier
About this trial
This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do so, a biological collection, including tissues of interest in the field of metabolism, will be collected during bariatric surgery in obese patients. Three different groups of metabolic status of patients, corresponding to different stages of evolution of the disease, will be constituted: type 2 diabetes, insulin resistance, insulin sensitivity.
The main objective is to compare, between these 3 groups of patients, several biological processes that may be involved in the pathophysiology of type 2 diabetes and disorders associated with obesity, including:
* Abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma, serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver) * Identification of metabolic signatures, protein and miRNA in plasma * Immunoinflammatory response in adipose tissue * Polymorphisms SNP from whole blood * Histological analysis of tissue sections This main objective will be studied on samples taken at the time of surgery Secondary objectives will be to study the changes in metabolites, proteins and miRNA in plasma level 3 and 12 months after the completion of surgery, according to the initial metabolic state.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Age 18 - 65 years inclusive at surgery
IMC > 35
Subject qualified for bariatric surgery (sleeve gastrectomy or gastric bypass)
Disqualifiers
Cancelled bariatric surgery
Tissue collection not possible during the bariatric surgery
Trial population
Subject qualified for bariatric surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Collection of blood samples and tissues
Other interventionCollection of blood samples and tissues during bariatric surgery and blood samples during followup visits
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: Type 2 diabetes1 intervention
Group B: Insulin resistance non diabetes1 intervention
Group C: Insulin sensitivity non diabetes1 intervention
Trial outcomes
Primary outcomes
1
comparison of metabolites
Time frame
At baseline (day of surgery)2
comparison of proteins levels
in liver, muscle, adipose tissue and plasma according to metabolic state
Time frame
At baseline (day of surgery)3
comparison of miRNA
in liver, muscle, adipose tissue and plasma according to metabolic state
Time frame
At baseline (day of surgery)Secondary outcomes
1
changes in metabolites in plasma level
Time frame
3 and 12 months after the completion of surgery2
changes in proteins in plasma level
Time frame
3 and 12 months after the completion of surgery3
changes in miRNA in plasma level
Time frame
3 and 12 months after the completion of surgerySponsors and contacts
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Source ClinicalTrials.gov