A Biological Atlas of Severe Obesity (Biological Tissue Collection)
Recruiting · NCT01129297 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital, Lille
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age between 18 and 65 years
- Indication of abdominal surgery requiring a laparotomy or laparoscopy for bariatric surgery, cholecystectomy, or parietal surgical
- Phenotype corresponding to one of the following four cases :
- 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)
- Body Mass Index ≥ 35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
- Body Mass Index \<27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
- \<Body Mass Index \<35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
Exclusion criteria
- 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
Where it is running
1 location listed.
- Lille University Hospital - Lille, Nord, France