Adipocyte, Insulin-resistance and Immunity : Evaluation of Interleukin-7 in Lipodystrophy, Diabetes and Obesity
IL-7norm
4 other identifiers
observational
126
1 country
5
Brief Summary
White adipose tissue-related diseases spread from excess (obesity) to lack (lipoatrophies) through aberrant distribution (lipodystrophies), these 3 different disorders being paradoxically able to induce a metabolic insulin resistance syndrome. The respective part of 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 perfectly understood in the metabolic syndrome yet. Therefore, the aim of this study is to assess different cytokines, especially interleukin 7, and metabolic parameters as well as fat mass distribution with DEXA and RMN, in different models of fat distribution, including normal-weight, obese and lipodystrophic patients. A plasma serum, gene and adipose tissue bank will be constituted at the same time to improve our knowledge in disorders linking fat mass, insulin resistance and immunity, especially in lipodystrophies, a rare monogenic model of insulin resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 14, 2026
February 1, 2017
5 years
August 9, 2011
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of blood Interleukin 7
1 day
Secondary Outcomes (14)
measure of blood Interleukins 2
1 day
measure of blood interleukin 9
1 day
measure of blood Interleukin 15
1 day
measure of blood TNF
1 day
measure of blood IL-1
1 day
- +9 more secondary outcomes
Study Arms (4)
normal
Patients with no overweight and no type 2 diabetes
lipodystrophy
patients with a lipodystrophy, most are diabetics
obese non diabetics
Patients with obesity (BMI \<30kg/m2), without diabetes
obese diabetics
Patients with obesity (BMI \<30 kg/m2), with diabetes
Eligibility Criteria
Patients with lipodystrophy : Endocrinology Departments of Lille , Amiens, Caen, Rouen and Reims University hospitals. Obese (diabetics and non diabetics) and normal weight patients : Endocrinology - Metabolism, Endocrine Surgery and Nutrition Departments, Lille University Hospital
You may qualify if:
- Male and Female
- More than 18 years old
- with lipodystrophic syndrome (familial, partial, genetically determined), diabetics or not, obese or not
- Patients with lipodystrophy non related to a lamine A/C gene mutation, diabetics or not, obese or not
- Obese without diabetes (BMI\> 30)
- Obese (BMI\>30) and diabetes according to ADA criteria
- Normal weight patients (18\< BMI\< 25)
- Agreement for the establishment of a serum bank and a plasma bank
You may not qualify if:
- Unable to receive enlightened information
- Refusal to sign the consent
- Corticosteroids (including inhaled), other immunosuppressing treatments (systemic disease for example) or immunomodulators (eg interferon);
- Creatinin \> 15 mg / L
- Sepsis
- Progressing cancers or autoimmune diseases;
- Treatment, disease or other condition that may affect the rate of IL-7 (as some contraceptives with estrogens)
- Bleeding disorders (due to disease or treatment)
- Active alcohol Intoxication
- Psychiatric pathology (after psychiatric consultation)
- Active infection including hepatitis C or HIV;
- Age under 18 years
- Participation in another study excluded the possibility of participating in another protocol
- BMI \> 60
- Secondary diabetes
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Amiens University Hospital
Amiens, 80054, France
Caen University Hospital
Caen, 14032, France
Lille University Hospital
Lille, 59037, France
Reims University Hospital
Reims, 51092, France
Rouen University Hospital
Rouen, 76031, France
Related Publications (1)
Lemaitre M, Chevalier B, Jannin A, Le Mapihan K, Boury S, Lion G, Labalette M, Vantyghem MC. Metabolic and immunological phenotype of rare lipomatoses: Dercum's disease and Roch-Leri mesosomatic lipomatosis. Orphanet J Rare Dis. 2021 Jun 29;16(1):290. doi: 10.1186/s13023-021-01920-3.
PMID: 34187516RESULT
Biospecimen
Wholeblood and tissue bank
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
marie christine VANTYGHEM, pHd
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2011
First Posted
February 5, 2013
Study Start
June 1, 2010
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 14, 2026
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share