Clinical trial NCT01907399: Study of Immune Response in Obesity and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Healthy Volunteers
Keywords: obese patients
obese patients with type 2 diabetes
healthy volunteers
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: quantification of Treg
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References: