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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01129297
Other study ID # 2006_0620
Secondary ID DGS 2006/0307
Status Recruiting
Phase Phase 0
First received May 4, 2010
Last updated November 23, 2016
Start date June 2006
Est. completion date January 2025

Study information

Verified date November 2016
Source University Hospital, Lille
Contact Francois PATTOU, MD PhD
Email fpattou@univ-lille2.fr
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20000
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Lille University Hospital Lille Nord

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Study the influence of phenotypic characteristics on gene expression of tissues involved in glucose metabolism 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 Baseline No
Secondary Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment) Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin 1 year No
Secondary Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment) Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin 2 years No
Secondary Correlation between gene expression and tissue insulin resistance index (HOMA2) (The Homeostasis Model Assessment) Insulin resistance is individually calculated by homeostasis model assessment(HOMA2) by determination of fasting glucose and insulin 5 years No
Secondary Prospective assessment of clinical and biological features before and after bariatric surgery 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) 1 year No
Secondary Prospective assessment of clinical and biological features before and after bariatric surgery 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) 2 years No
Secondary Prospective assessment of clinical ans biological features before and after bariatric surgery 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) 5 years No
Secondary Genotype-Phenotype correlation Genotype-Phenotype correlation based on medical and family history Baseline No
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