Immunodeficiency Secondary to Organ Transplantation Clinical Trial
— IL-7tranOfficial title:
Adipocytes, Insulin Resistance and Immunity: Evolution of Interleukin 7, Fat Mass and Metabolic Profile Before and After Transplantation
Verified date | June 2018 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Three different white adipose tissue-related disorders, whether due to its excess (obesity), absence (lipoatrophies) or aberrant distribution (lipodystrophies), are paradoxically able to induce metabolic insulin resistance syndrome. The respective roles played by quantitative and qualitative anomalies of adipose tissue, gluco- and lipo-toxicity, liver and muscle insulin resistance, low-grade fat inflammation and immune alterations are not yet perfectly understood. In contrast to most organ transplantations that are often complicated by post-transplantation diabetes, diabetes cell therapy is associated with body weight loss, which is possibly related to the antiadipogenic effects of mTOR inhibitors (rapamycin or sirolimus). The aim of this study is thus to determine and monitor blood interleukin-7 and other cytokine levels; metabolic parameters; and fat mass distribution with DEXA and RMN, before and after a immunosuppressive regimen in patients receiving different kinds of transplantation (liver, kidney or islets) with normal weight and no type 2 diabetes before transplantation. In these patients, blood samples will be taken before and after transplantation, as will adipose tissue during the transplantation surgery, in order to constitute a plasma serum, gene and tissue bank for improving our knowledge of disorders linking fat mass, insulin resistance and immunity, especially post-transplantation diabetes.
Status | Completed |
Enrollment | 49 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male and Female - More than 18 years old - BMI inferior to 30 kg/m2 - non diabetic patients who need a kidney or a liver transplantation(Glucose blood level <1,26 g/L without any antidiabetic drug) - OR included in the islet transplantation protocol because of a C peptide negative brittle or difficult to treat diabetes. - cover under the social security Exclusion Criteria: - Unable to receive enlightened information - Refusal to sign the consent - Auto immune disease (kidney, liver or chronic inflammatory disease) - need for a kidney-pancreas transplantation - Creatinin > 15 mg / L for patients non concerned by kidney transplantation - Sepsis - Oestrogens, raloxifene - Active alcohol Intoxication - Cancers or autoimmune diseases; - Psychiatric Pathology - Active infection including hepatitis C or HIV; - Age under 18 years or above 65 years - Participation in another study excluded the possibility of participating in another protocol - No cover under the social security - Pregnant or lactating women - patients under guardianship, persons deprived of liberty |
Country | Name | City | State |
---|---|---|---|
France | Amiens University Hospital | Amiens | |
France | Caen University Hospital | Caen | |
France | Lille University Hospital | Lille | |
France | Reims University Hospital | Reims | |
France | Rouen University Hospital | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | interleukin 7 | 1 year | ||
Secondary | Interleukin 2 | 1 year | ||
Secondary | Interleukin 4 | 1 year | ||
Secondary | Interleukin 9 | 1 year | ||
Secondary | Interleukin 15 | 1year | ||
Secondary | Interleukin 21 | 1year | ||
Secondary | TNFa | 1 year | ||
Secondary | Interleukin 1b | 1 year | ||
Secondary | Interleukin 6 | 1year | ||
Secondary | Interleukin 8 | 1 year | ||
Secondary | Interleukin 10 | 1 year | ||
Secondary | Interleukin 18 | 1 year | ||
Secondary | leptin | 1 year | ||
Secondary | adiponectin | 1 year | ||
Secondary | Blood cells of innate and adaptative immunity analysis | 1 year | ||
Secondary | fat mass | 1 year | ||
Secondary | metabolic parameters | 1 years |