Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01129297

A Biological Atlas of Severe Obesity (Biological Tissue Collection)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille University Hospital

Lille, Nord, France

Location status: Recruiting

Location contact

François PATTOU, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

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

Treatment and study plan

Primary outcomes

  1. Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolism

    Time frame: Baseline

    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

Secondary outcomes

  1. Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)

    Time frame: 1 year

    Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin

  2. Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)

    Time frame: 2 years

    Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin

  3. Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)

    Time frame: 5 years

    Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin

  4. Prospective assessment of clinical and biological features before and after bariatric surgery

    Time frame: 1 year

    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)

  5. Prospective assessment of clinical and biological features before and after bariatric surgery

    Time frame: 2 years

    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 and fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)

  6. Prospective assessment of clinical ans biological features before and after bariatric surgery

    Time frame: 5 years

    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 and fasting insulin, blood glucose and insulin 120 minutes after ingestion of glucose (oral glucose tolerance test)

  7. Genotype-Phenotype correlation

    Time frame: Baseline

    Genotype-Phenotype correlation based on medical and family history

Study contacts

Contact information is provided by the study sponsor or research team.

Francois PATTOU, MD PhD

CONTACT

[email protected]

Violeta Raverdy, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: ABOS

Important dates

Study start
2006
Primary completion
2027
Study completion
2027
First posted
May 24, 2010
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.