Evolution of Interleukin 7, Fat Mass and Metabolic Profile Before and After Transplantation
IL-7tran
Adipocytes, Insulin Resistance and Immunity: Evolution of Interleukin 7, Fat Mass and Metabolic Profile Before and After Transplantation
4 other identifiers
observational
49
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2010
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2010
CompletedFirst Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJune 7, 2018
June 1, 2018
7.7 years
August 10, 2011
June 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
interleukin 7
1 year
Secondary Outcomes (16)
Interleukin 2
1 year
Interleukin 4
1 year
Interleukin 9
1 year
Interleukin 15
1year
Interleukin 21
1year
- +11 more secondary outcomes
Study Arms (3)
islet
type 1 diabetic patients undergoing islet transplantation
liver
non diabetic patients undergoing a liver transplantation
kidney
non diabetic patients undergoing a kidney transplantation
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Amiens University Hospital
Amiens, France
Caen University Hospital
Caen, France
Lille University Hospital
Lille, France
Reims University Hospital
Reims, France
Rouen University Hospital
Rouen, France
Biospecimen
wholeblood and tissue bank
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-Christine VANTYGHEM, MD, PhD
Lille University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 11, 2011
Study Start
June 9, 2010
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
June 7, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share