Adipocyte, Insulin-resistance and Immunity : Evaluation of Interleukin-7 in Lipodystrophy, Diabet… (NCT01784289) | Clinical Trial Compass
CompletedNot Applicable
Adipocyte, Insulin-resistance and Immunity : Evaluation of Interleukin-7 in Lipodystrophy, Diabetes and Obesity
France126 participantsStarted 2010-06
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* No social security
* Pregnant or lactating women, patients under guardianship, persons deprived of liberty
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.