<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03260452</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/15/7739</org_study_id>
    <secondary_id>2017-A01697-46</secondary_id>
    <nct_id>NCT03260452</nct_id>
  </id_info>
  <brief_title>Comparison of Hematopoietic Stem Cell Activity in Adipose Tissue From Type 2 Diabetic Patients and Healthy Volunteers</brief_title>
  <acronym>WAT2DO</acronym>
  <official_title>Comparison of Hematopoietic Stem Cell Activity in Adipose Tissue From Type 2 Diabetic Patients and Healthy Volunteers: Proof of Concept Study. White Adipose Tissue and Type 2 Diabetes Onset: WAT2DO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on solid preclinical results in mice and preliminary data in humans, this study aims to&#xD;
      provide the proof of concept of the crucial role of the hematopoietic process occurring in&#xD;
      human adipose tissue in the initiation of the inflammatory process at the origin of insulin&#xD;
      resistance and type 2 diabetes (T2D). The main objective is to compare the number of&#xD;
      pro-inflammatory macrophages derived from human adipose tissue hematopoietic stem cells (HSC)&#xD;
      according to their origin, type 2 diabetes subjects or healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In mice, increasing data demonstrate a causal relationship between the inflammatory process&#xD;
      in adipose tissue and the development of insulin resistance, resulting in type 2 diabetes&#xD;
      occurrence. However, the mechanisms mediating inflammation and its metabolic consequences are&#xD;
      still unclear. In humans, recent publications have suggested an important interaction between&#xD;
      the metabolic status and medullar hematopoietic activity. A preliminary study performed by&#xD;
      the STROMAlab's research team has identified functional hematopoietic stem cells in human&#xD;
      adipose tissue samples, indicating that adipose tissue-hematopoiesis is an active mechanism.&#xD;
&#xD;
      To determine whether an alteration in adipose tissue-hematopoiesis could be a hallmark of&#xD;
      type 2 diabetes in human, biopsies of subcutaneous adipose tissue will be performed in 2&#xD;
      groups of 10 volunteers: overweight/obese type 2 diabetes subjects versus healthy volunteers,&#xD;
      matched on age.&#xD;
&#xD;
      Then, hematopoietic stem cells extracted from human biopsies will be grafted into&#xD;
      immunodeficient mice and after 12 weeks, flow cytometry using antibodies specific for human&#xD;
      cell surface markers will be performed to quantify proinflammatory macrophages derived from&#xD;
      human adipose tissue-hematopoietic stem cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2018</start_date>
  <completion_date type="Actual">January 24, 2019</completion_date>
  <primary_completion_date type="Actual">January 24, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>20 male volunteers: 10 overweight/obese subjects with T2D and 10 healthy volunteers, age-matched.&#xD;
All volunteers will be treated in the same way.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>All laboratory analyses will be performed blindly.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of pro-inflammatory macrophages derived from human adipose tissue in mice transplanted with adipose tissue-hematopoietic stem cells .</measure>
    <time_frame>Day 3 - Day 45</time_frame>
    <description>The investigators expect that the number of pro-inflammatory macrophages derived from human adipose tissue will be significantly higher in mice transplanted with adipose tissue-hematopoietic stem cells isolated from diabetic subjects compared to those from healthy volunteers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of hematopoietic activity in vitro between both groups of subjects.</measure>
    <time_frame>Day 3 - Day 45</time_frame>
    <description>Evaluated by flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the number of the other cell types derived from the human adipose tissue-hematopoietic stem cells between both groups of grafted mice.</measure>
    <time_frame>Day 3 - Day 45</time_frame>
    <description>Evaluated by flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the phenotype of the other cell types derived from the human adipose tissue-hematopoietic stem cells between both groups of grafted mice.</measure>
    <time_frame>Day 3 - Day 45</time_frame>
    <description>Evaluated by flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the expression of genes coding for human inflammatory molecules in the adipose tissue of transplanted mice.</measure>
    <time_frame>Day 3 - Day 45</time_frame>
    <description>Evaluated by Real-Time Quantitative Reverse Transcription Polymerase Chain Reaction. Main parameters analysed : Interleukin-6, Interleukin-1béta, Plasminogen activator inhibitor-1, Monocyte Chemoattractant Protein-1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the metabolic profile of the transplanted mice evaluated by the grafted mice's glycemia.</measure>
    <time_frame>Day 3 - Day 45</time_frame>
    <description>According to the origin of the grafted hematopoietic stem cells (diabetic or healthy voluntary subjects).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the metabolic profile of the transplanted mice evaluated by the grafted mice's insulinemia.</measure>
    <time_frame>Day 3 - Day 45</time_frame>
    <description>According to the origin of the grafted hematopoietic stem cells (diabetic or healthy voluntary subjects).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the metabolic profile of the transplanted mice evaluated by the grafted mice's oral glucose tolerance test.</measure>
    <time_frame>Day 3 - Day 45</time_frame>
    <description>According to the origin of the grafted hematopoietic stem cells (diabetic or healthy voluntary subjects).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>'Abdominal subcutaneous biopsies and Blood test'</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Abdominal subcutaneous biopsies and Blood test</intervention_name>
    <description>Abdominal subcutaneous biopsies and blood test for each volunteer.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No major weight variation for at least 3 months&#xD;
&#xD;
          -  Biological assessment without clinically significant anomaly from the point of view of&#xD;
             the investigator.&#xD;
&#xD;
          -  Acceptance of constraints related to participation in the study&#xD;
&#xD;
          -  Acceptance of participation in the constitution of a cell bank, a tissue bank and a&#xD;
             serum library.&#xD;
&#xD;
          -  Affiliation to a social security scheme.&#xD;
&#xD;
        Type 2 diabetic subjects:&#xD;
&#xD;
          -  Type 2 diabetes (discovered after the age of 35 years, without inaugural ketosis and&#xD;
             absence of insulin therapy during the first year).&#xD;
&#xD;
          -  40 to 60 year-old.&#xD;
&#xD;
          -  BMI between 27 and 35 kg / m² (included).&#xD;
&#xD;
          -  Treated by modification of lifestyle alone or associated to oral anti-diabetic therapy&#xD;
             only.&#xD;
&#xD;
          -  With stable oral anti-diabetic treatment for at least 3 months.&#xD;
&#xD;
          -  HbA1c ≤ 8.5%.&#xD;
&#xD;
        Healthy Volunteers:&#xD;
&#xD;
          -  BMI between 23 and 27 kg / m² (included).&#xD;
&#xD;
          -  37 to 63 year-old, age-matched to a type 2 diabetes subject ± 5 years.&#xD;
&#xD;
          -  Fasting blood glucose &lt; 1,10 g / L.&#xD;
&#xD;
          -  HbA1c within normal limits (4 to 6%).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Excessive chronic alcohol consumption (&gt; 30 g / day or 210 g / week).&#xD;
&#xD;
          -  Tobacco consumption&gt; 10 cigarettes / day that cannot be stopped for 24 hours.&#xD;
&#xD;
          -  Anti-diabetic treatments that require sub-cutaneous injections&#xD;
&#xD;
          -  History of chronic or acute hematological pathology.&#xD;
&#xD;
          -  Systemic or acute inflammatory pathology.&#xD;
&#xD;
          -  Treatment with antiplatelet agents, non-steroidal anti-inflammatory drugs,&#xD;
             glucocorticoids (excluding eye drops and sprays), or other immunosuppressive drugs.&#xD;
&#xD;
          -  History of cancer (except basal cell carcinoma).&#xD;
&#xD;
          -  Allergy to xylocaine or one of its derivatives.&#xD;
&#xD;
          -  Any significant pathology at the discretion of the investigator.&#xD;
&#xD;
          -  Any biological anomaly at the discretion of the investigator.&#xD;
&#xD;
          -  Positive human immunodeficiency virus serology.&#xD;
&#xD;
          -  Positive hepatitis B serology.&#xD;
&#xD;
          -  Positive hepatitis C serology.&#xD;
&#xD;
          -  Glomerular filtration rate less than 60 ml / min&#xD;
&#xD;
          -  Aspartate aminotransferase or alanine aminotransferase higher than 2.5-fold the upper&#xD;
             normal value.&#xD;
&#xD;
          -  Hypertriglyceridemia &gt; 2.5 g / l&#xD;
&#xD;
          -  Person under the protection of justice, guardianship or curators.&#xD;
&#xD;
          -  Subject involved in another research protocol or in an exclusion period from another&#xD;
             research protocol.&#xD;
&#xD;
          -  Cognitive disorder or mental pathology (at the discretion of the investigator).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>37 Years</minimum_age>
    <maximum_age>63 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre GOURDY</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Toulouse - Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Casteilla L, Planat-Benard V, Laharrague P, Cousin B. Adipose-derived stromal cells: Their identity and uses in clinical trials, an update. World J Stem Cells. 2011 Apr 26;3(4):25-33. doi: 10.4252/wjsc.v3.i4.25.</citation>
    <PMID>21607134</PMID>
  </reference>
  <reference>
    <citation>Bour S, Caspar-Bauguil S, Iffiu-Soltesz Z, Nibbelink M, Cousin B, Miiluniemi M, Salmi M, Stolen C, Jalkanen S, Casteilla L, Penicaud L, Valet P, Carpene C. Semicarbazide-sensitive amine oxidase/vascular adhesion protein-1 deficiency reduces leukocyte infiltration into adipose tissue and favors fat deposition. Am J Pathol. 2009 Mar;174(3):1075-83. doi: 10.2353/ajpath.2009.080612. Epub 2009 Feb 13.</citation>
    <PMID>19218346</PMID>
  </reference>
  <reference>
    <citation>Brooks-Worrell B, Narla R, Palmer JP. Biomarkers and immune-modulating therapies for type 2 diabetes. Trends Immunol. 2012 Nov;33(11):546-53. doi: 10.1016/j.it.2012.07.002. Epub 2012 Aug 14.</citation>
    <PMID>22897868</PMID>
  </reference>
  <reference>
    <citation>Cancello R, Clement K. Is obesity an inflammatory illness? Role of low-grade inflammation and macrophage infiltration in human white adipose tissue. BJOG. 2006 Oct;113(10):1141-7. doi: 10.1111/j.1471-0528.2006.01004.x. Epub 2006 Aug 10.</citation>
    <PMID>16903845</PMID>
  </reference>
  <reference>
    <citation>Caspar-Bauguil S, Cousin B, Bour S, Casteilla L, Penicaud L, Carpene C. Adipose tissue lymphocytes: types and roles. J Physiol Biochem. 2009 Dec;65(4):423-36. doi: 10.1007/BF03185938. Erratum In: J Physiol Biochem. 2011 Sep;67(3):497. Castiella, L [corrected to Casteilla, L].</citation>
    <PMID>20358356</PMID>
  </reference>
  <reference>
    <citation>Cousin B, Andre M, Arnaud E, Penicaud L, Casteilla L. Reconstitution of lethally irradiated mice by cells isolated from adipose tissue. Biochem Biophys Res Commun. 2003 Feb 21;301(4):1016-22. doi: 10.1016/s0006-291x(03)00061-5.</citation>
    <PMID>12589814</PMID>
  </reference>
  <reference>
    <citation>Dalmas E, Tordjman J, Guerre-Millo M, Clement K. [Adipose tissue, a new playground for immune cells]. Med Sci (Paris). 2011 Nov;27(11):993-9. doi: 10.1051/medsci/20112711016. Epub 2011 Nov 30. French.</citation>
    <PMID>22130027</PMID>
  </reference>
  <reference>
    <citation>Han J, Koh YJ, Moon HR, Ryoo HG, Cho CH, Kim I, Koh GY. Adipose tissue is an extramedullary reservoir for functional hematopoietic stem and progenitor cells. Blood. 2010 Feb 4;115(5):957-64. doi: 10.1182/blood-2009-05-219923. Epub 2009 Nov 6.</citation>
    <PMID>19897586</PMID>
  </reference>
  <reference>
    <citation>Nagareddy PR, Murphy AJ, Stirzaker RA, Hu Y, Yu S, Miller RG, Ramkhelawon B, Distel E, Westerterp M, Huang LS, Schmidt AM, Orchard TJ, Fisher EA, Tall AR, Goldberg IJ. Hyperglycemia promotes myelopoiesis and impairs the resolution of atherosclerosis. Cell Metab. 2013 May 7;17(5):695-708. doi: 10.1016/j.cmet.2013.04.001.</citation>
    <PMID>23663738</PMID>
  </reference>
  <reference>
    <citation>Nikolajczyk BS, Jagannathan-Bogdan M, Denis GV. The outliers become a stampede as immunometabolism reaches a tipping point. Immunol Rev. 2012 Sep;249(1):253-75. doi: 10.1111/j.1600-065X.2012.01142.x.</citation>
    <PMID>22889227</PMID>
  </reference>
  <reference>
    <citation>Poglio S, De Toni-Costes F, Arnaud E, Laharrague P, Espinosa E, Casteilla L, Cousin B. Adipose tissue as a dedicated reservoir of functional mast cell progenitors. Stem Cells. 2010 Nov;28(11):2065-72. doi: 10.1002/stem.523.</citation>
    <PMID>20845475</PMID>
  </reference>
  <reference>
    <citation>Poglio S, De Toni F, Lewandowski D, Minot A, Arnaud E, Barroca V, Laharrague P, Casteilla L, Cousin B. In situ production of innate immune cells in murine white adipose tissue. Blood. 2012 Dec 13;120(25):4952-62. doi: 10.1182/blood-2012-01-406959. Epub 2012 Oct 15.</citation>
    <PMID>23071275</PMID>
  </reference>
  <reference>
    <citation>Prunet-Marcassus B, Cousin B, Caton D, Andre M, Penicaud L, Casteilla L. From heterogeneity to plasticity in adipose tissues: site-specific differences. Exp Cell Res. 2006 Apr 1;312(6):727-36. doi: 10.1016/j.yexcr.2005.11.021. Epub 2005 Dec 28.</citation>
    <PMID>16386732</PMID>
  </reference>
  <reference>
    <citation>Richardson VR, Smith KA, Carter AM. Adipose tissue inflammation: feeding the development of type 2 diabetes mellitus. Immunobiology. 2013 Dec;218(12):1497-504. doi: 10.1016/j.imbio.2013.05.002. Epub 2013 May 16.</citation>
    <PMID>23816302</PMID>
  </reference>
  <reference>
    <citation>Shapiro H, Lutaty A, Ariel A. Macrophages, meta-inflammation, and immuno-metabolism. ScientificWorldJournal. 2011;11:2509-29. doi: 10.1100/2011/397971. Epub 2011 Dec 28.</citation>
    <PMID>22235182</PMID>
  </reference>
  <reference>
    <citation>Spinetti G, Cordella D, Fortunato O, Sangalli E, Losa S, Gotti A, Carnelli F, Rosa F, Riboldi S, Sessa F, Avolio E, Beltrami AP, Emanueli C, Madeddu P. Global remodeling of the vascular stem cell niche in bone marrow of diabetic patients: implication of the microRNA-155/FOXO3a signaling pathway. Circ Res. 2013 Feb 1;112(3):510-22. doi: 10.1161/CIRCRESAHA.112.300598. Epub 2012 Dec 18.</citation>
    <PMID>23250986</PMID>
  </reference>
  <reference>
    <citation>Weisberg SP, McCann D, Desai M, Rosenbaum M, Leibel RL, Ferrante AW Jr. Obesity is associated with macrophage accumulation in adipose tissue. J Clin Invest. 2003 Dec;112(12):1796-808. doi: 10.1172/JCI19246.</citation>
    <PMID>14679176</PMID>
  </reference>
  <reference>
    <citation>Xu H, Barnes GT, Yang Q, Tan G, Yang D, Chou CJ, Sole J, Nichols A, Ross JS, Tartaglia LA, Chen H. Chronic inflammation in fat plays a crucial role in the development of obesity-related insulin resistance. J Clin Invest. 2003 Dec;112(12):1821-30. doi: 10.1172/JCI19451.</citation>
    <PMID>14679177</PMID>
  </reference>
  <reference>
    <citation>Ito R, Takahashi T, Katano I, Ito M. Current advances in humanized mouse models. Cell Mol Immunol. 2012 May;9(3):208-14. doi: 10.1038/cmi.2012.2. Epub 2012 Feb 13.</citation>
    <PMID>22327211</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Adipose tissue</keyword>
  <keyword>Hematopoiesis</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Macrophages</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260452
org study id: RC31/15/7739
secondary id: 2017-A01697-46
nct id: NCT03260452
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Based on solid preclinical results in mice and preliminary data in humans, this study aims to
      provide the proof of concept of the crucial role of the hematopoietic process occurring in
      human adipose tissue in the initiation of the inflammatory process at the origin of insulin
      resistance and type 2 diabetes (T2D). The main objective is to compare the number of
      pro-inflammatory macrophages derived from human adipose tissue hematopoietic stem cells (HSC)
      according to their origin, type 2 diabetes subjects or healthy volunteers.
In mice, increasing data demonstrate a causal relationship between the inflammatory process
      in adipose tissue and the development of insulin resistance, resulting in type 2 diabetes
      occurrence. However, the mechanisms mediating inflammation and its metabolic consequences are
      still unclear. In humans, recent publications have suggested an important interaction between
      the metabolic status and medullar hematopoietic activity. A preliminary study performed by
      the STROMAlab's research team has identified functional hematopoietic stem cells in human
      adipose tissue samples, indicating that adipose tissue-hematopoiesis is an active mechanism.

      To determine whether an alteration in adipose tissue-hematopoiesis could be a hallmark of
      type 2 diabetes in human, biopsies of subcutaneous adipose tissue will be performed in 2
      groups of 10 volunteers: overweight/obese type 2 diabetes subjects versus healthy volunteers,
      matched on age.

      Then, hematopoietic stem cells extracted from human biopsies will be grafted into
      immunodeficient mice and after 12 weeks, flow cytometry using antibodies specific for human
      cell surface markers will be performed to quantify proinflammatory macrophages derived from
      human adipose tissue-hematopoietic stem cells.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 20 male volunteers: 10 overweight/obese subjects with T2D and 10 healthy volunteers, age-matched.
All volunteers will be treated in the same way.
primary purpose: Basic Science
masking: None (Open Label)
masking description: All laboratory analyses will be performed blindly.
measure: Number of pro-inflammatory macrophages derived from human adipose tissue in mice transplanted with adipose tissue-hematopoietic stem cells .
time frame: Day 3 - Day 45
description: The investigators expect that the number of pro-inflammatory macrophages derived from human adipose tissue will be significantly higher in mice transplanted with adipose tissue-hematopoietic stem cells isolated from diabetic subjects compared to those from healthy volunteers.
measure: Comparison of hematopoietic activity in vitro between both groups of subjects.
time frame: Day 3 - Day 45
description: Evaluated by flow cytometry.
measure: Comparison of the number of the other cell types derived from the human adipose tissue-hematopoietic stem cells between both groups of grafted mice.
time frame: Day 3 - Day 45
description: Evaluated by flow cytometry.
measure: Comparison of the phenotype of the other cell types derived from the human adipose tissue-hematopoietic stem cells between both groups of grafted mice.
time frame: Day 3 - Day 45
description: Evaluated by flow cytometry.
measure: Comparison of the expression of genes coding for human inflammatory molecules in the adipose tissue of transplanted mice.
time frame: Day 3 - Day 45
description: Evaluated by Real-Time Quantitative Reverse Transcription Polymerase Chain Reaction. Main parameters analysed : Interleukin-6, Interleukin-1béta, Plasminogen activator inhibitor-1, Monocyte Chemoattractant Protein-1.
measure: Comparison of the metabolic profile of the transplanted mice evaluated by the grafted mice's glycemia.
time frame: Day 3 - Day 45
description: According to the origin of the grafted hematopoietic stem cells (diabetic or healthy voluntary subjects).
measure: Comparison of the metabolic profile of the transplanted mice evaluated by the grafted mice's insulinemia.
time frame: Day 3 - Day 45
description: According to the origin of the grafted hematopoietic stem cells (diabetic or healthy voluntary subjects).
measure: Comparison of the metabolic profile of the transplanted mice evaluated by the grafted mice's oral glucose tolerance test.
time frame: Day 3 - Day 45
description: According to the origin of the grafted hematopoietic stem cells (diabetic or healthy voluntary subjects).
arm group label: Patients
arm group type: Experimental
description: 'Abdominal subcutaneous biopsies and Blood test'
intervention type: Procedure
intervention name: Abdominal subcutaneous biopsies and Blood test
description: Abdominal subcutaneous biopsies and blood test for each volunteer.
arm group label: Patients
criteria: 
gender: Male
minimum age: 37 Years
maximum age: 63 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pierre GOURDY
role: Principal Investigator
affiliation: CHU Toulouse
facility: 
country: France
citation: Casteilla L, Planat-Benard V, Laharrague P, Cousin B. Adipose-derived stromal cells: Their identity and uses in clinical trials, an update. World J Stem Cells. 2011 Apr 26;3(4):25-33. doi: 10.4252/wjsc.v3.i4.25.
PMID: 21607134
citation: Bour S, Caspar-Bauguil S, Iffiu-Soltesz Z, Nibbelink M, Cousin B, Miiluniemi M, Salmi M, Stolen C, Jalkanen S, Casteilla L, Penicaud L, Valet P, Carpene C. Semicarbazide-sensitive amine oxidase/vascular adhesion protein-1 deficiency reduces leukocyte infiltration into adipose tissue and favors fat deposition. Am J Pathol. 2009 Mar;174(3):1075-83. doi: 10.2353/ajpath.2009.080612. Epub 2009 Feb 13.
PMID: 19218346
citation: Brooks-Worrell B, Narla R, Palmer JP. Biomarkers and immune-modulating therapies for type 2 diabetes. Trends Immunol. 2012 Nov;33(11):546-53. doi: 10.1016/j.it.2012.07.002. Epub 2012 Aug 14.
PMID: 22897868
citation: Cancello R, Clement K. Is obesity an inflammatory illness? Role of low-grade inflammation and macrophage infiltration in human white adipose tissue. BJOG. 2006 Oct;113(10):1141-7. doi: 10.1111/j.1471-0528.2006.01004.x. Epub 2006 Aug 10.
PMID: 16903845
citation: Caspar-Bauguil S, Cousin B, Bour S, Casteilla L, Penicaud L, Carpene C. Adipose tissue lymphocytes: types and roles. J Physiol Biochem. 2009 Dec;65(4):423-36. doi: 10.1007/BF03185938. Erratum In: J Physiol Biochem. 2011 Sep;67(3):497. Castiella, L [corrected to Casteilla, L].
PMID: 20358356
citation: Cousin B, Andre M, Arnaud E, Penicaud L, Casteilla L. Reconstitution of lethally irradiated mice by cells isolated from adipose tissue. Biochem Biophys Res Commun. 2003 Feb 21;301(4):1016-22. doi: 10.1016/s0006-291x(03)00061-5.
PMID: 12589814
citation: Dalmas E, Tordjman J, Guerre-Millo M, Clement K. [Adipose tissue, a new playground for immune cells]. Med Sci (Paris). 2011 Nov;27(11):993-9. doi: 10.1051/medsci/20112711016. Epub 2011 Nov 30. French.
PMID: 22130027
citation: Han J, Koh YJ, Moon HR, Ryoo HG, Cho CH, Kim I, Koh GY. Adipose tissue is an extramedullary reservoir for functional hematopoietic stem and progenitor cells. Blood. 2010 Feb 4;115(5):957-64. doi: 10.1182/blood-2009-05-219923. Epub 2009 Nov 6.
PMID: 19897586
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responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No