Screening Patients With Diabetes Mellitus for the Presence of Scleredema Adultorum of Buschke and Characterize Clinical-laboratory Findings of the Newly Identified Cases: a Single-center, Prospective, Obsevational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- presence of atherogen dyslipidemia
研究概览
简要总结
Scleredema is a scleroderma-like skin disorder appearing in 2.5-14% among patients with type 1 or 2 diabetes mellitus. This is a single centre study to screen consecutive patients with diabetes mellitus for the presence of scleredema,and to compare the clinical-laboratory data of patients with and without scleredema. Metabolic and vascular complications of these patients will be focused on.
详细描述
Scleredema adultorum of Buschke is a scleroderma-like skin disorder characterized by thickened skin with edema in patients' neck, shoulders and back. Graff described three types of scleredema. The first type occurs usually in children after an infection, the second type often associated with haematological malignancies and the third type usually develops in patients with long lasting uncontrolled diabetes mellitus. These patients with diabetes are often obese and have vascular complications. Based on two large cohorts, the prevalence of scleredema among patients with diabetes mellitus was 2.5-14.0% .
The aims of this study is to screen consecutive patients with diabetes mellitus for the presence of scleredema skin disorder and to investigate and compare the clinical-laboratory data of patients with and without scleredema. Both the vascular complications in case history and the parameters of lipid and carbohydrate metabolism will be focused on. All findings will also be compared to another cohort of scleredema-diabetes patients who already treated in our tertiary clinical centre of the University of Pécs in Hungary.
Participants and methods:
About 150 consecutive patients with diabetes mellitus are planned to be investigated. Scleredema skin disorder will be screened by palpation of skin on the nape of the neck, the whole trunk and the shoulders by at least two physicians. Newly recognized patients will be asked to give their consent for undergoing skin biopsy.
Planned clinical examinations and biochemical data collection are as follows:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus is based on the criteria of the World Health Organization (WHO),
- •The duration of diabetes mellitus must be longer than one year.
排除标准
- •Patients taking any forms of glucocorticoids in the previous year.
结局指标
主要结局
presence of atherogen dyslipidemia
时间窗: during the whole study, 60 months
elevated triglycerides (≥1.7 mmol/l) and decreased HDL-cholesterol (\<1.03 mmol/l in males and \<1.29 mmol/l in females) in the sera
presence of incresed non-HDL cholesterol level of the sera
时间窗: during the whole study, 60 months
Serum non-HDL cholesterol was calculated by subtracting HDL-cholesterol from the total cholesterol levels of the sera.
次要结局
- Hepatic steatosis index(during the whole study, 60 months)
- Number of vascular complications in patients' medical histories, earlier, than our investigation time(during the whole study, 60 months)
- Prevalence of polyneuropathy(during the whole study, 60 months)
研究者
dr Varjú Cecília
Associate Professor, MD, PhD
University of Pecs