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

U

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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