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Study of Immune Response in Obesity and Type 2 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01907399
Acronym
IMMUNOBEDIA
Enrollment
101
Registered
2013-07-25
Start date
2010-09-30
Completion date
2014-04-30
Last updated
2018-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Obesity, Type 2 Diabetes

Keywords

obese patients, obese patients with type 2 diabetes, healthy volunteers

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.

Interventions

OTHERBlood samples

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
quantification of Tregbaseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026