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Comparison of Hematopoietic Stem Cell Activity in Adipose Tissue From Type 2 Diabetic Patients and Healthy Volunteers (WAT2DO)

1. april 2019 opdateret af: University Hospital, Toulouse

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Toulouse, Frankrig, 31059
        • CHU de Toulouse - Rangueil

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

37 år til 63 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • No major weight variation for at least 3 months
  • Biological assessment without clinically significant anomaly from the point of view of the investigator.
  • Acceptance of constraints related to participation in the study
  • Acceptance of participation in the constitution of a cell bank, a tissue bank and a serum library.
  • Affiliation to a social security scheme.

Type 2 diabetic subjects:

  • Type 2 diabetes (discovered after the age of 35 years, without inaugural ketosis and absence of insulin therapy during the first year).
  • 40 to 60 year-old.
  • BMI between 27 and 35 kg / m² (included).
  • Treated by modification of lifestyle alone or associated to oral anti-diabetic therapy only.
  • With stable oral anti-diabetic treatment for at least 3 months.
  • HbA1c ≤ 8.5%.

Healthy Volunteers:

  • BMI between 23 and 27 kg / m² (included).
  • 37 to 63 year-old, age-matched to a type 2 diabetes subject ± 5 years.
  • Fasting blood glucose < 1,10 g / L.
  • HbA1c within normal limits (4 to 6%).

Exclusion Criteria:

  • Excessive chronic alcohol consumption (> 30 g / day or 210 g / week).
  • Tobacco consumption> 10 cigarettes / day that cannot be stopped for 24 hours.
  • Anti-diabetic treatments that require sub-cutaneous injections
  • History of chronic or acute hematological pathology.
  • Systemic or acute inflammatory pathology.
  • Treatment with antiplatelet agents, non-steroidal anti-inflammatory drugs, glucocorticoids (excluding eye drops and sprays), or other immunosuppressive drugs.
  • History of cancer (except basal cell carcinoma).
  • Allergy to xylocaine or one of its derivatives.
  • Any significant pathology at the discretion of the investigator.
  • Any biological anomaly at the discretion of the investigator.
  • Positive human immunodeficiency virus serology.
  • Positive hepatitis B serology.
  • Positive hepatitis C serology.
  • Glomerular filtration rate less than 60 ml / min
  • Aspartate aminotransferase or alanine aminotransferase higher than 2.5-fold the upper normal value.
  • Hypertriglyceridemia > 2.5 g / l
  • Person under the protection of justice, guardianship or curators.
  • Subject involved in another research protocol or in an exclusion period from another research protocol.
  • Cognitive disorder or mental pathology (at the discretion of the investigator).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patients
'Abdominal subcutaneous biopsies and Blood test'
Procedure: Abdominal subcutaneous biopsies and Blood test
Abdominal subcutaneous biopsies and blood test for each volunteer.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of pro-inflammatory macrophages derived from human adipose tissue in mice transplanted with adipose tissue-hematopoietic stem cells .
Tidsramme: Day 3 - Day 45
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.
Day 3 - Day 45

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of hematopoietic activity in vitro between both groups of subjects.
Tidsramme: Day 3 - Day 45
Evaluated by flow cytometry.
Day 3 - Day 45
Comparison of the number of the other cell types derived from the human adipose tissue-hematopoietic stem cells between both groups of grafted mice.
Tidsramme: Day 3 - Day 45
Evaluated by flow cytometry.
Day 3 - Day 45
Comparison of the phenotype of the other cell types derived from the human adipose tissue-hematopoietic stem cells between both groups of grafted mice.
Tidsramme: Day 3 - Day 45
Evaluated by flow cytometry.
Day 3 - Day 45
Comparison of the expression of genes coding for human inflammatory molecules in the adipose tissue of transplanted mice.
Tidsramme: Day 3 - Day 45
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.
Day 3 - Day 45
Comparison of the metabolic profile of the transplanted mice evaluated by the grafted mice's glycemia.
Tidsramme: Day 3 - Day 45
According to the origin of the grafted hematopoietic stem cells (diabetic or healthy voluntary subjects).
Day 3 - Day 45
Comparison of the metabolic profile of the transplanted mice evaluated by the grafted mice's insulinemia.
Tidsramme: Day 3 - Day 45
According to the origin of the grafted hematopoietic stem cells (diabetic or healthy voluntary subjects).
Day 3 - Day 45
Comparison of the metabolic profile of the transplanted mice evaluated by the grafted mice's oral glucose tolerance test.
Tidsramme: Day 3 - Day 45
According to the origin of the grafted hematopoietic stem cells (diabetic or healthy voluntary subjects).
Day 3 - Day 45

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Toulouse

Efterforskere

  • Ledende efterforsker: Pierre GOURDY, CHU Toulouse

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. juni 2018

Primær færdiggørelse (Faktiske)

24. januar 2019

Studieafslutning (Faktiske)

24. januar 2019

Datoer for studieregistrering

Først indsendt

27. juli 2017

Først indsendt, der opfyldte QC-kriterier

21. august 2017

Først opslået (Faktiske)

24. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC31/15/7739
  • 2017-A01697-46 (Anden identifikator: ID-RCB)

Plan for individuelle deltagerdata (IPD)

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Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med Abdominal subcutaneous biopsies and Blood test

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