IMMUNOBEDIA: Study of Immune Response in Obesity and Type 2 Diabetes

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT01907399
Collaborator
(none)
101
1
3
43
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood samples
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Actual Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: obese patients

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

Other: Blood samples

Other: obese patients with type 2 diabetes

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

Other: Blood samples

Other: healthy volunteers

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

Other: Blood samples

Outcome Measures

Primary Outcome Measures

  1. quantification of Treg [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Dijon Dijon France 21079

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01907399
Other Study ID Numbers:
  • Bonnotte PHRC IR 2010
First Posted:
Jul 25, 2013
Last Update Posted:
Dec 27, 2018
Last Verified:
Dec 1, 2018
Keywords provided by Centre Hospitalier Universitaire Dijon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 27, 2018