Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Change from Baseline HbA1c at 3 months, 6 months
研究概览
简要总结
This study is a retrospective review of participants who visited Department of Endocrinology, Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis months, from January 2015 to December 2020. All the participants should be diagnosed as type 2 diabetes mellitus, obesity and dyslipidemia. Therapeutic effect of traditional Chinese medicine will be evaluated based on the changes of blood glucose, body mass index, blood lipids, and blood pressure.
详细描述
The diagnostic criteria for type 2 diabetes mellitus and obesity are based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition). The diagnostic criteria of dyslipidaemia are based on the Chinese Guidelines on Prevention and Treatment of Dyslipidaemia in Adults (2016, revision edition).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet at least three of the requirements below; 1) Fasting Plasma Glucose > 6.1 mmol/L or 2-hour Postprandial Blood Glucose > 7.8 mmol/L or diagnosed as type 2 diabetes mellitus; 2) Body Mass Index > 25 kg / m2; 3) Total Cholesterol > 5.2 mmol / L; Or Triglyceride > 1.70 mmol / L; Or Low-Density Lipoprotein > 3.12 mmol / L; Or High-Density Lipoprotein < 1.04 mmol/L. 4) Systolic blood pressure > 130 mmHg or Diastolic blood pressure > 85 mmHg or diagnosed as hypertension;
- •Received 6 months of continuous Chinese herbal medicine treatment;
- •During the period of receiving Chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before.
- •During the period of receiving Chinese herbal medicine, diet and exercise continued according to the original routine, and the tests would be reviewed in the same institution.
- •Aged 18 to 80 years at the time of their consent;
- •Signed informed consent.
排除标准
- •Patients who had serious heart, lung, liver, kidney and brain diseases; serious infectious or hemorrhagic diseases; serious nervous system diseases, mental instability; or could not cooperate with treatment were excluded.
研究组 & 干预措施
Observational group
干预措施: Chinese herb medicine (Drug)
结局指标
主要结局
Change from Baseline HbA1c at 3 months, 6 months
时间窗: 0 month, 3 months, 6 months
Changes from Baseline Fasting Blood Glucose at 3 months, 6 months
时间窗: 0 month, 3 months, 6 months
Changes from Baseline Low Density Lipoprotein at 3 months, 6 months
时间窗: 0 month, 3 months, 6 months
Changes from Baseline Triglyceride at 3 months, 6 months
时间窗: 0 month, 3 months, 6 months
Changes from Baseline Body Mass Index at 3 months, 6 months
时间窗: 0 month, 3 months, 6 months
次要结局
- Changes from Postprandial Blood Glucose at 6 months(0 month, 6 months)
- Changes from Total Cholesterol at 6 months(0 month, 6 months)
- Changes from Systolic Blood Pressure at 6 months(0 month, 6 months)
- Changes from High Density Lipoprotein at 6 months(0 month, 6 months)
- Changes from Diastolic Blood Pressure at 6 months(0 month, 6 months)
研究者
Jiaxing Tian
Attending Physician, Department of Endocrinology
Guang'anmen Hospital of China Academy of Chinese Medical Sciences