Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- glucose intolerance or diabetes
研究概览
简要总结
Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not well known. The purpose of this study is to research a carbohydrate metabolism disorder associated in bexarotene-induced hypertriglyceridemia.
详细描述
Primary cutaneous lymphomas are the second group of extra nodal lymphomas after gastrointestinal lymphomas. Bexarotene is licensed for the treatment of epidermotropic cutaneous T cell lymphoma .The most common side effect of bexarotene is hypertriglyceridemia (82%) associated with hypercholesterolemia (30 to 40%). Central hypothyroidism is also present in 40-80% of cases. These adverse effects are dose-dependent. The management of hyperlipidemia induced by bexarotene is difficult. The mechanism of lipid disorder induced by bexarotene is not well known. Associated carbohydrate metabolism disorder could be present and play a role in the bexarotene-induced hyperlipidemia.
The main objective is to estimate the frequency of a carbohydrate disorder in patients with hypertriglyceridemia (TG> 1.5 g / L) induced by bexarotene treatment of cutaneous T cell lymphoma, previously free of diabetes, thyroid dysfunction and dyslipidemia.
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
- 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
- •Patient aged over 18 years
- •Diagnosis of epidermotropic CTCL confirmed by histological examination for which consideration will be given treatment with bexarotene due to the advanced stage of lymphoma (stage IIB-IV) or earlier stage if resistance to previous treatment .
- •TSH, FT3 and FT4 within normal limits
- •AST and ALT ≤ 2 * upper limit of normal
- •Creatinine clearance ≥ 30 mL / min
- •Agreement after written information and informed to participate in the study
- •Patient accepting the constraints of the study
- •Membership of a social security system.
排除标准
- •Pregnant or lactating woman
- •Women of childbearing potential without effective contraception
- •Insufficient thyroid or hyperthyroidism
- •Diabetes known or detected
- •Hyperlipidemia known or detected
- •Hepatic insufficiency
- •Difficulties to understand
- •Persons covered by a plan of legal protection (protection of justice, guardianship, curator) or unable to issue a consent
研究组 & 干预措施
bexarotene
干预措施: oral glucose tolerance test (OGTT) (Other)
结局指标
主要结局
glucose intolerance or diabetes
时间窗: At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
The presence of a carbohydrate disorder is defined by glucose intolerance or diabetes. The diagnosis of glucose intolerance is made for a fasting glucose less than 1.26 g / l glucose and 2 hours (T120mn) after taking 75 g of glucose during an oral glucose tolerance test (OGTT) between 1.4 and 2 g / l and / or a value greater than or equal to 2 g / l between T30 and T90 min. Diabetes is established for a fasting glucose greater than or equal to 1.26 g / l and / or blood glucose greater than or equal to 2 g / l to 2 hours.
次要结局
- hypothyroidism(At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.)
- response to bexarotene(At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.)