Evaluation of Adipokines and Fat Tissue in Psoriasis and Psoriatic Arthritis and Assessment of Their Relations With the Risk of Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)
研究概览
简要总结
Body composition analysis and especially body fat distribution in regions of interest (android and in particular intra-abdominal region) provides some information on the risk of cardiovascular disease. There is little data available on the body composition analysis in psoriasis and psoriatic arthritis (diseases with higher risk of cardiovascular disease), in particular data on fat distribution in regions of interest regarding the risk of cardiovascular disease.
Adipokines, secreted by the adipose tissue, have pro or anti-inflammatory and metabolic properties that are interesting to explore in pathologies with a higher risk of cardiovascular disease like psoriasis or psoriatic arthritis.
Adipokines have been investigated in psoriasis but fat tissue and in particular its distribution (android/visceral or intra-abdominal) has not been studied in parallel. Moreover, relation between adipokines and psoriasis area or severity has been studied but the relation between adipokines and cardiovascular risk factors has not yet been investigated.
The aim of this study is to investigate relations between the body fat distribution, adipokines rates and the risk of cardiovascular disease of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of psoriasis vulgaris or psoriasis pustulosa confirmed by a dermatologist or a diagnosis of psoriatic arthritis (CASPAR criteria) confirmed by a rheumatologist
- •Age ≥ 18 and ≤ 80 years old
- •Control group: patients matching with sex, age ± 5 years, BMI (4 groups), coming to the same hospital for a consultation.
- •(BMI groups : BMI < 18,5 kg/m²; 18,5 ≤ BMI ≤ 24,99 kg/m²; 25≤ BMI ≤ 29,99 kg/m²; BMI ≥ 30 kg/m²) Control group patients for psoriatic arthritis will be included during a rheumatologist consultation. They may have a non-inflammatory common disco-vertebral pathology (lumbago, lumbosciatic, spinal stenosis, neck pain, cervical arthritis and cervicobrachial neuralgia).
- •Control group patients for psoriasis will be included during a dermatologist consultation. They may have a non-inflammatory skin disease (acne, acne rosacea, idiopathic Raynaud's phenomenon, basal cell carcinoma, acanthosis nigricans).
- •In case of recruitment difficulties, healthy volunteers can be included.
- •Postmenopausal women (for at least 24 months), surgically sterilized, or for women of childbearing age, efficacy use of contraceptive methods (contraceptive pills, injections or patches, intra-uterine device, double-barrier contraception),
- •Signature of informed consent form
- •French social security Affiliation
排除标准
- •Pregnant woman
- •Corticosteroid therapy >10 mg of prednisone or equivalent /day
- •Patients taking biological therapy (anti-TNFalpha therapy: infliximab, etanercept, adalimumab, golimumab, certolizumab ; anti-Interleukin-12/Interleukin-23: ustekinumab).
- •Legal incapacity or limited legal capacity
- •Presence of any condition hampering compliance with the study protocol, at the discretion of the investigator
- •No french social security affiliation
研究组 & 干预措施
Psoriasis and arthritic psoriasis
additional blood sample for biological analyses bone densitometry questionnaires
干预措施: bone densitometry (Other)
Psoriasis and arthritic psoriasis
additional blood sample for biological analyses bone densitometry questionnaires
干预措施: questionnaires (Other)
Psoriasis and arthritic psoriasis
additional blood sample for biological analyses bone densitometry questionnaires
干预措施: biological analyses (Other)
结局指标
主要结局
Android fat distribution measured by bone densitometry (DEXA) (LUNAR GE iDXA device)
时间窗: day 1
次要结局
- Body fat(day 1)
- body masses(day 1)
- Homeostasis model assessment of insulin resistance(day 1)
- Intra-abdominal body fat mass (measured by CoreScan)(day 1)
- SCORE (Systematic COronary Risk Evaluation).(day 1)
- levels of adipokines(day 1)
- levels of ghrelin(day 1)
- Gynoid distribution of body fat(day 1)
- Bone mineral density of rachis, femoral neck, whole body(day 1)