We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Biological Atlas of Severe Obesity (Biological Tissue Collection) (ABOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01129297
Recruitment Status : Recruiting
First Posted : May 24, 2010
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Phase
Obesity Glucose Intolerance Diabetes Early Phase 1

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.


Study Design

Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)
Study Start Date : June 2006
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
BMI ≥ 35 kg/m2 and diabetes
BMI (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 (oral glucose tolerance test)
BMI ≥ 35 kg/m2 with intolerance glucose
BMI (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 (oral glucose tolerance test)
BMI ≥ 35 kg/m2 without diabetes
BMI (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 (oral glucose tolerance test)
BMI <27 kg/m2 without diabetes
BMI (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 (oral glucose tolerance test)
27 < BMI < 35 kg/m2 without diabetes
BMI (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 (oral glucose tolerance test)


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
  • Liver samples before and at 1 and 5 years after bariatric surgery
  • Muscle samples before and at 1 year after bariatric surgery
  • Subcutaneous fat samples before and at 3 month and 1 year after bariatric surgery
  • Visceral fat samples in the great omentum before bariatric surgery
  • Intestinal samples during gastric by-pass surgery
  • Blood samples

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Recruiting: Clinical Medical Center from the north of France
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129297


Contacts
Contact: Francois PATTOU, MD PhD fpattou@univ-lille2.fr
Contact: Violeta Raverdy, MD vraverdi@univ-lille2.fr

Locations
France
Lille University Hospital Recruiting
Lille, Nord, France
Contact: François PATTOU, MD, PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Francois PATTOU, MD PhD Lille University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01129297     History of Changes
Other Study ID Numbers: 2006_0620
DGS 2006/0307 ( Other Identifier: AFSSAPS )
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Lille:
Obesity
surgery
genetic expression
collection of samples

Additional relevant MeSH terms:
Obesity
Glucose Intolerance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases