Study of Immune Response in Obesity and Type 2 Diabetes

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Healthy Volunteers Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Dijon

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

Other

Primary outcomes

quantification of Treg

Time frame: baseline

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: IMMUNOBEDIA

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Jul 25, 2013
Registry last updated: Dec 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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