A Biological Atlas of Severe Obesity (Biological Tissue Collection)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity Hospital, Lille
About this trial
Type 2 diabetes and obesity are both multifactorial diseases resulting from gene-environment interactions. However, this interaction, as well as the specific effect of each polymorphism, remains poorly understood.
We now proposed a prospective cohort study to improve our understanding of the influence of phenotypic characteristics on gene expression in tissues involved in glucose and/or lipid metabolism by collecting different biological samples.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 65 years
Indication of abdominal surgery requiring a laparotomy or laparoscopy for bariatric surgery, cholecystectomy, or parietal surgical
Body Mass Index ≥ 35 kg/m2 and diabetes defined by a fasting blood glucose ≥ 7 mmol/l and/or ≥ to 11.1 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
Body Mass Index ≥ 35 kg/m2 with intolerance glucose defined by a fasting blood glucose> 6 mmol/L and <7 mmol/l and/or> 7.8 mmol/l and <11.1 mmol/l , 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
Disqualifiers
unable to receive clear information
refusal to sign the consent form
pathology associated judged by the surgeon, may increase the risk of adverse events related to sampling tissue
Trial population
Recruiting: Clinical Medical Center from the north of France
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20,000 Participants
are grouped into 5 trial groupsGroup A: BMI ≥ 35 kg/m2 and diabetes
Group B: BMI ≥ 35 kg/m2 with intolerance glucose
Group C: BMI ≥ 35 kg/m2 without diabetes
Group D: BMI <27 kg/m2 without diabetes
Group E: 27 < BMI < 35 kg/m2 without diabetes
Trial outcomes
Primary outcomes
1
Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolism
Study the correlation between the glycemic status (fasting glucose and / or after ingestion of glucose) adjusted to the presence or absence of obesity (Body Mass Index) and gene expression in tissues involved in glucose metabolism before bariatric surgery
Time frame
BaselineSecondary outcomes
1
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)
Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
Time frame
1 year2
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)
Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
Time frame
2 years3
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)
Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
Time frame
5 years4
Prospective assessment of clinical and biological features before and after bariatric surgery
Prospective assessment of clinical and biological features before and after bariatric surgery: weight, BMI, blood pressure, alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), prothrombin time, platelets, serum triglyceride, cholesterolemia, fasting blood glucose, fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov