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Study of Immune Response in Obesity and Type 2 Diabetes

NCT ID: NCT01907399

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Type 2 Diabetes Healthy Volunteers

Keywords

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obese patients obese patients with type 2 diabetes healthy volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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obese patients

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

Group Type OTHER

Blood samples

Intervention Type 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

Group Type OTHER

Blood samples

Intervention Type OTHER

healthy volunteers

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

Group Type OTHER

Blood samples

Intervention Type OTHER

Interventions

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Blood samples

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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Bonnotte PHRC IR 2010

Identifier Type: -

Identifier Source: org_study_id