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A Biological Atlas of Severe Obesity (Biological Tissue Collection)

Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01129297
Acronym
ABOS
Enrollment
20000
Registered
2010-05-24
Start date
2006-06-13
Completion date
2027-06-30
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Glucose Intolerance, Obesity

Keywords

Obesity, surgery, genetic expression, collection of samples

Brief summary

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.

Detailed description

Type 2 diabetes (T2D) is a disease commonly associated with obesity, which is an important risk factor for this condition. More than 80% of the diabetic subjects are obese. By analogy with the metabolic syndrome, the close association between obesity and T2D justifies the recognition of a new disease entity named by the neologism diabesity. This study will examine the contribution of different genetic variants on diabesity development, by integrating multiple genomics approaches (linkage analysis on whole genome, transcriptomics and bioinformatics) and analysis of biological pathways in relevant animals models and humans.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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 : 1. 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) 2. 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) 3. 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) 4. 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) 5)27 \<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

Design outcomes

Primary

MeasureTime frameDescription
Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolismBaselineStudy 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

Secondary

MeasureTime frameDescription
Genotype-Phenotype correlationBaselineGenotype-Phenotype correlation based on medical and family history
Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)1 yearInsulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin
Prospective assessment of clinical and biological features before and after bariatric surgery1 yearProspective 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)
Prospective assessment of clinical ans biological features before and after bariatric surgery5 yearsProspective 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 and fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)

Countries

France

Contacts

Primary ContactFrancois PATTOU, MD PhD
fpattou@univ-lille2.fr
Backup ContactVioleta Raverdy, MD
vraverdi@univ-lille2.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026