Clozapine Induced Weight Gain: A Pharmacogenetic Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Body-mass index (BMI)
研究概览
简要总结
Clozapine is prescribed to patients with psychosis in whom other treatments have not worked. Research has shown, however, that clozapine may be associated with weight gain and abnormal blood sugar levels in some patients. There is strong evidence to suggest that genetic variation between individuals plays an important role in the development of these side effects in response to the medication. Our research aims to evaluate the effects of two genes and the blood level of clozapine on side-effects such as weight changes and blood sugar levels in patients receiving clozapine treatment. From out-patient clinics in Cwm Taf UHB, the investigators aim to recruit 160 patients who are taking clozapine; collect information/ measurements from recruits relating to size/ weight/ BMI, risk of diabetes and blood samples to measure markers of blood sugar, fat/lipids, clozapine and its breakdown products, blood cells and variants of two specific genes. From this information the investigators will be particularly interested to understand if there is any association between the variation in these two genes with weight gain or changes in blood sugar, in patients taking clozapine.
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
- •Age 18 years or over
- •Taking/compliant with clozapine antipsychotic medications.
- •Patients meeting the ICD-10 criteria for a diagnosis of schizophrenia, schizoaffective or borderline personality disorders.
排除标准
- •History of current alcohol/illicit substance dependency.
- •Unable/ unsuitable to complete the study protocol e.g. acutely ill, suicidal or aggressive patients.
- •Unable to consent to the study.
结局指标
主要结局
Body-mass index (BMI)
时间窗: 12 months
BMI will be calculated by weight (kg)/ height\^2 (m\^2).
Serotonin 5-HT 2C receptor gene single nucleotide polymorphisms (SNPs) (rs3813929)
时间窗: 12 months
SNPs will be determined by polymerase chain reaction followed by restriction fragment length polymorphism analysis to determine (c.-759C or c.-759T) .
Leptin gene promoter region single nucleotide polymorphisms (SNPs) (rs7799039)
时间窗: 12 months
SNPs will be determined by polymerase chain reaction followed by restriction fragment length polymorphism analysis to determine (c.-2548G or c.-2548A) .
次要结局
- Blood haemoglobin A1c concentration(6 months)
- Clozapine:nor clozapine ratio(12 months)
- Clozapine side effects assessment by Clinical Global Impression (CGI) scale(12 months)
- Waist:hip ratio(12 months)
- Lipid profile(12 months)