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Clinical Trials/NCT01129297
NCT01129297
Recruiting
Not Applicable

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

University Hospital, Lille1 site in 1 country20,000 target enrollmentJune 13, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University Hospital, Lille
Enrollment
20000
Locations
1
Primary Endpoint
Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolism
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 13, 2006
End Date
June 1, 2027
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility 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 :
  • 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)
  • 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

Outcomes

Primary Outcomes

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

  • Prospective assessment of clinical ans biological features before and after bariatric surgery(5 years)
  • Genotype-Phenotype correlation(Baseline)
  • Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment)(5 years)
  • Prospective assessment of clinical and biological features before and after bariatric surgery(2 years)

Study Sites (1)

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