Study of Immune Response in Obesity and Type 2 Diabetes

NCT01907399 | Completed

• 1 other identifier: Bonnotte PHRC IR 2010
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes; Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• quantification of Treg

  baseline

Study Arms (3)

obese patients

OTHER

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

Other: Blood samples

obese patients with type 2 diabetes

OTHER

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

Other: Blood samples

healthy volunteers

OTHER

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

Other: Blood samples

Interventions

Blood samples OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de Dijon

Dijon, 21079, France

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 25, 2013
• Study Start: September 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 27, 2018

Record last verified: 2018-12

Locations

FR (1)