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临床试验/NCT03548103
NCT03548103已完成不适用

Green Tea Extract for Obesity of Psychiatric Patients: a Double Blind Placebo-controlled Trial

Taipei City Hospital2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Body weight change in patients treated with psychotropic medications

研究概览

简要总结

Obesity or metabolic syndrome is becoming a global epidemic and common health problem, leading to the increase of associated comorbidities such as type 2 diabetes, cardiovascular disease, and certain cancers. This phenomenon is also a serious problem among psychiatric patients due to the increase use of second generation antipsychotics and mood stabilizers such as lithium or valproic acid. These metabolic abnormalities can be regarded as medical comorbidities, and have an impact not only on physical health and increased hospital length of stay, but also on a lower functional outcome, low self-esteem and poorer quality of life and non-compliance to antipsychotics. Green tea is one of the most popular beverages in the world and is believed to have beneficial effects in prevention and treatment of many diseases, such as cancer-prevention, adjunct to chemotherapy for malignancy, to reduce mental and physical stress and improve memory function, to increase bone mineral density, and to decrease body weight. Since weight gain is a common and undesirable side effect with psychiatric medications, the management of it becomes an important issue in clinical practice. In this clinical trial, we will use decaffeinated green tea extract to treat overweight patients with schizophrenia or bipolar disorder in a double-blind, placebo-controlled study design.

详细描述

Prevalence of obesity or metabolic syndrome and diabetes:

Obesity or metabolic syndrome is becoming a global epidemic and common health problem. The rising prevalence of obesity and associated comorbidities such as type 2 diabetes, cardiovascular disease, and certain cancers represents a major threat to public health worldwide. In a recent study in Asian populations, the result showed a strong association between BMI and prevalence of diabetes. From the results of a general population survey in Taiwan, the overall prevalence of obesity (body mass index (BMI) ≧ 27 kg/m2) in men and women was 19.2% and 13.4%, respectively, while the age-standardized prevalence of MS was 15.7% by the modified Adult Treatment Panel III criteria, 14.3% by the International Diabetes Federation for Chinese criteria and 16.4% by the metabolic syndrome criteria for Taiwanese. Their data also showed that the prevalence of obesity and metabolic syndrome significantly increased with age (trend test, p < 0.0001) in men and women. The risk of metabolic syndrome and its components increased significantly with BMI, and showed a marked increase with BMI≧24 kg/m2.

Prevalence of obesity or metabolic syndrome and diabetes in psychiatric patients:

The prevalence of MS among patients with schizophrenia or other psychotic disorder has been reported to be high, ranging from 24% to 43% in males and from 27% to 52% in females in previous large-scale investigations. These metabolic abnormalities can be regarded as medical comorbidities, and have an impact not only on physical health and increased hospital length of stay, but also on a lower functional outcome, low self-esteem and poorer quality of life and lead to non-compliant to antipsychotics.

In Taiwan, a large scale survey on 650 patients with schizophrenia or schizoaffective disorder from 36 community psychiatric rehabilitation centers or hospital-affiliated day hospitals in Taipei area revealed an overall metabolic syndrome prevalence of 34.9%, with 38.9% in female and 31.5% in male patients, respectively. The difference of metabolic syndrome prevalence between those patients and the general population was marked in male patients under 40 years of age and in female patients under 50. The authors suggested that BMI≧24 kg/m2 and age over 40 years old are two important risk factors of metabolic syndrome. Since the implementation of second generation antipsychotics (SGAs), especially clozapine, olanzapine or quetiapine, the metabolic syndrome prevalence exaggerated. Bai and her associates (2009) carried a large survey on 567 hospitalized of patients with schizophrenia under SGAs (clozapine =231, olanzapine n=94 and risperidone =242) for an average duration of 45.8+/-27.8 months, and revealed the prevalence of metabolic syndrome among all subjects was 23.8%. The clozapine group had a higher prevalence of metabolic syndrome (28.7%) than did the olanzapine (24.2%) and risperidone groups (19.5%) (P=0.039), and the clozapine group had lower levels of adiponectin (8.46+/-6.02 mg/mL) than did the olanzapine (10.26+/-4. 9 mg/mL) and risperidone groups (10.69+/-7.43 mg/mL) (P=0.001). The authors also found that adiponectin level was negatively correlated with BMI increase after initiation of SGAs treatment. Beside the increase use of SGAs, the use of mood stabilizers such as lithium or valproic acid in patients with bipolar disorder can also lead to body weight increment and metabolic syndrome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Placebo

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients with schizophrenia or mood disorders, followed at Taipei City Psychiatric Center will be the targeted study population. The subjects should fulfill the following criteria:
  • Age between 20 to 65 years.
  • Currently taking antipsychotics or mood stabilizers.
  • BMI should be ≥ 27 kg/m
  • Good adherence to medications as recorded by chart.
  • Competent to understand the informed consent and have motivation to decrease their body weight.

排除标准

  • Unstable psychiatric symptoms or physical condition that may interfere the adherence of medication.
  • Medical conditions such as endocrine disease, heart disease, allergy or immunology disease, or impaired liver function (high aminotransferases, alanine, aspartate >80 IU/L or serum creatinine >2.5 mg/dl.
  • Pregnant or lactating women.
  • Childbirth within 6 months.
  • Management for weight control within 3 months.
  • Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.

结局指标

主要结局

Body weight change in patients treated with psychotropic medications

时间窗: 16 weeks

Body weight decreas in kilogram after treatment

次要结局

  • Change of metabolic biochemistry profile composite(16 weeks)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Lin, Shih-Ku

Chair, Department of Psychiatry

Taipei City Hospital

研究点 (2)

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