Study of Immune Response in Obesity and Type 2 Diabetes (IMMUNOBEDIA)

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Healthy Volunteers; Obesity; Type 2 Diabetes

Treatments: Other: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT01907399

Bonnotte PHRC IR 2010

Details and patient eligibility

About

There is a link between activation of the immune response inducing chronic inflammation and both obesity and type 2 diabetes. To date, however, the cause(s) of this inflammation, the mechanisms of the inflammatory cascade and the type of cells involved are not completely known. The aim of our project is to study the principal cell types involved in the immune response from a quantitative and functional point of view in obese diabetic patients versus obese non-diabetic patients and healthy subjects who are neither diabetic nor obese.

Despite possible inter-individual heterogeneity of immune cells, the fact that this work will be carried out by an accredited team with considerable expertise in the study of almost all the different types of immune cells will probably make it possible to know whether cell dysfunction and inflammation are associated with obesity or rather linked to insulin resistance. This study will be completed later by a second study on cell infiltration in adipose tissues in the 3 groups defined above. Better understanding of the physiopathology and especially the mechanisms and type of cells involved in obesity-related inflammation could quickly lead to the development of appropriate therapies that could act specifically on the cells involved and thus preclude the onset of complications.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient-control who have given written informed consent Patient-control who are covered by the National Health Insurance Agency Patient-control > 18 years old

The criteria to classify patients into groups will be as follows:

Group 1- Obese diabetics BMI > 30 Kg /m2 AND fasting glycemia > 1.26 g/L AND Triglycerides >1.5g/L AND HDL <0.4g/L (men), <0.5g/L (women) Group 2- Obese non-diabetics without metabolic syndrome BMI > 30 Kg /m2 AND fasting glycemia < 1.10 g/L AND Triglycerides <1.5g/L AND HDL >0.4g/L (men), >0.5g/L (women) Group 3- Healthy Subjects BMI < 25 Kg/m² AND fasting glycemia < 1.10g/L AND Triglycerides <1.5g/L

Exclusion criteria

• Persons not covered by the National Health Insurance Agency Patients who presented a recent infection, or cancer or patients treated with corticosteroids or anti-inflammatory drugs. Patients with diabetes following an overload disease (hemochromatosis) or due to a disease of the pancreas Chronic infection Pregnant women Patients on the following treatments (glitazone: Actos, Avendia; GLP1 Agonist: Byetta, Victoza; Fibrates) Patients presenting severe renal insufficiency with clearance<30ml/min

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

obese patients

Other group

Description:

(BMI\> 30 kg/m2) androids (waist circumference\> 102 cm in men and\> 88 cm in woman)

Treatment:

Other: Blood samples

obese patients with type 2 diabetes

Other group

Description:

(BMI\> 30 kg/m2) androids (waist circumference\> 102 cm in men and\> 88 cm in woman)with diabetes

Treatment:

Other: Blood samples

healthy volunteers

Other group

Description:

free of disease inflammatory or infectious and will have a BMI \<25 Kg/m2et fasting glucose \<1g / L

Treatment:

Other: Blood samples