Cyclophosphamide in the Treatment of Panniculitis Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Average daily insulin dosage
研究概览
简要总结
This study evaluates the change of insulin resistance and glucose metabolism of patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes with the treatment of cyclophosphamide.
详细描述
Patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes have difficulty in blood glucose management due to the presence of both severe insulin resistance and complete insulin deficiency. It is often necessary to use insulin doses several times that of other children of the same age with type 1 diabetes.
Since autoimmune response is the main cause of panniculitis associated acquired lipodystrophy syndrome, immunosuppressive agents can suppress immune response, prevent and alleviate the progression of panniculitis and acquired lipodystrophy syndrome, and improve insulin resistance caused by subcutaneous fat deficiency.
Cyclophosphamide is a classic immunosuppressive agent. This study hopes to improve insulin resistance of patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes by cyclophosphamide treatment, thereby reducing insulin dosage and improving glucose metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of type 1 diabetes mellitus: clinical manifestations of typical diabetes mellitus include polyphagia, polyuria, weight loss, or diabetic ketoacidosis, confirmed by blood sugar level, islet function and autoimmune antibody.
- •Meet the diagnostic criteria for panniculitis: fat biopsy suggests inflammatory infiltration.
- •Meet the diagnostic criteria for acquired lipodystrophy syndrome: childhood onset, clinically no nutritional deficiency or catabolism, systemic or partial subcutaneous fat reduction, genetic testing to exclude congenital lipodystrophy syndrome; low leptin level and autoantibodies can aid in diagnosis.
排除标准
- •Mature and effective treatment methods are available.
- •HIV, HBV and HCV were positive.
- •A the active period of infection.
- •At the active stage of malignant tumors.
- •Combination of other fatal diseases.
- •Existence of mental and psychological diseases.
研究组 & 干预措施
Interventional
Drug:Cyclophosphamide Dosage form: intravenous infusion Dosage: 500 mg/m2 of BSA Frequency: every 4 weeks Duration: 24 weeks
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Average daily insulin dosage
时间窗: week 21
Average daily insulin dosage of continuous three days (the average of the 1st, 2nd and 3rd days' insulin requirements after the last cyclophosphamide treatment, the blood glucose meets the ISPAD guideline as premeal 4.0-7.0 mmol/L, postmeal 5.0-10.0 mmol/L, prebed 4.4-7.8 mmol/L)
次要结局
- HbA1c level(week 1)
- HbA1c level(week 5)
- HbA1c level(from the completion of treatment to 6 months)
- HbA1c level(week 9)
- HbA1c level(week 13)
- HbA1c level(week 17)
- HbA1c level(week 21)
- HbA1c level(from the completion of treatment to 3 months)
- HbA1c level(from the completion of treatment to 9 months)
- HbA1c level(from the completion of treatment to 12 months)
- Average daily insulin dosage(from the completion of treatment to 12 months)
- Average daily insulin dosage(week 1)
- Average daily insulin dosage(week 5)
- Average daily insulin dosage(week 9)
- Average daily insulin dosage(week 13)
- Average daily insulin dosage(week 17)
- Average daily insulin dosage(from the completion of treatment to 3 months)
- Average daily insulin dosage(from the completion of treatment to 6 months)
- Average daily insulin dosage(from the completion of treatment to 9 months)