NCT06107439已完成不适用
Impact of Lipodystrophy on the Inflammatory State of Non-diabetic Dunnigan Reunion Island Subjects
Centre Hospitalier Universitaire de la Réunion3 个研究点 分布在 2 个国家目标入组 64 人开始时间: 2023年8月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- pro-inflammatory markers
研究概览
简要总结
Few data and small numbers affect the inflammatory profile of Dunnigan patients. The levels of certain pro-inflammatory biomarkers would be found higher in these subjects compared to control individuals. However, in these studies, several confounding factors were not taken into account such as smoking, an underlying chronic inflammatory disease such as diabetes and could limit the interpretation of the results. There is no other observation of the anti-inflammatory status 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
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subject (>18 years old) affected by partial Dunnigan lipodystrophy in the homozygous or heterozygous state (genetic search for the positive mutation carried out before inclusion in the study).
- •Person affiliated to or beneficiary of a social security scheme.
- •Free, informed and written consent signed by the participant and the investigator.
排除标准
- •Persons placed under judicial protection, person participating in another research including a period of exclusion still in progress, severely impaired physical and/or psychological health, which, according to the investigator, may affect the participant's compliance with the study
- •Previous known diabetes
- •Pregnant woman
- •Woman who gave birth less than 6 months ago
- •Breastfeeding in progress
- •Participation in other research that may have an impact on the evaluation of the main judgment criteria
- •Hemoglobin b level < 7 mg/dl or < 9-10 mg/dl for patients with cardiovascular or respiratory pathology.
- •Proven inflammatory pathologies
- •Anti-inflammatory treatment: taking corticosteroids in the last 3 months.
- •Active smoking
研究组 & 干预措施
sampling and clinical data collection
Other
Participant blood and urine are sampled for inflammatory signal analysis
干预措施: Bood and urine sampling (Biological)
结局指标
主要结局
pro-inflammatory markers
时间窗: inclusion day
blood sample and dosage of pro inflammatory cytokine
次要结局
未报告次要终点
研究者
研究点 (3)
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