Evolution of Interleukin 7, Fat Mass and Metabolic Profile Before and After Transplantation (IL-7tran)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Immunodeficiency Secondary to Organ Transplantation |
Procedure: transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Adipocytes, Insulin Resistance and Immunity: Evolution of Interleukin 7, Fat Mass and Metabolic Profile Before and After Transplantation |
- interleukin 7 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Interleukin 2 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Interleukin 4 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Interleukin 9 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Interleukin 15 [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
- Interleukin 21 [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
- TNFa [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Interleukin 1b [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Interleukin 6 [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
- Interleukin 8 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Interleukin 10 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Interleukin 18 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- leptin [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- adiponectin [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Blood cells of innate and adaptative immunity analysis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- fat mass [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- metabolic parameters [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
wholeblood and tissue bank
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
islet
type 1 diabetic patients undergoing islet transplantation
|
Procedure: transplantation
transplantation of islet, kidney or liver
Other Name: transplantation
|
|
liver
non diabetic patients undergoing a liver transplantation
|
Procedure: transplantation
transplantation of islet, kidney or liver
Other Name: transplantation
|
|
kidney
non diabetic patients undergoing a kidney transplantation
|
Procedure: transplantation
transplantation of islet, kidney or liver
Other Name: transplantation
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients undergoing a transplantation in Endocrinology Metabolism department, Nephrology department and Liver Transplantation department in Lille University Hospital, Amiens University Hospital, Caen University Hospital, Rouen University Hospital and Reims University Hospital.
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
Contacts and Locations| Contact: Marie Christine VANTYGHEM, PhD | +33 3 20 44 45 35 | mc-vantyghem@chru-lille.fr |
| France | |
| Amiens University Hospital | Recruiting |
| Amiens, France | |
| Contact: Rachel DESAILLOUD, MD PhD +33 3 22 45 58 95 r.desailloud@voila.fr | |
| Caen University Hospital | Recruiting |
| Caen, France | |
| Contact: Yves REZNIK, MD PhD +33 2 31 06 45 85 reznik-y@chu-caen.fr | |
| Lille University Hospital | Recruiting |
| Lille, France | |
| Contact: Marie Christin VANTYGHEM, MD PhD +33 3 20 44 45 35 mc-vantyghem@chru-lille.fr | |
| Reims University Hospital | Recruiting |
| Reims, France | |
| Contact: Brigitte DELEMER, MD PhD +33 3 26 78 71 59 bdelemer@chu-reims.fr | |
| Rouen University Hospital | Recruiting |
| Rouen, France | |
| Contact: Herve LEFEBVRE, MD PhD +33 2 32 88 90 81 lefebvre@chru-rouen.fr | |
| Principal Investigator: | Marie-Christine VANTYGHEM, MD, PhD | Lille University Hospital |
More Information
No publications provided
| Responsible Party: | University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01414660 History of Changes |
| Other Study ID Numbers: | 2009_09/0940, 2009_09/0940, B91413-80, PHRC 2009/API |
| Study First Received: | August 10, 2011 |
| Last Updated: | April 24, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Lille:
|
interleukin 7 transplantation liver |
kidney islet diabetes |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013