Exploration of Early Diagnosis of Diabetes Mellitus Type 2 Based on Traditional Chinese Medicine by MERID Diagnostics, Biophoton Measurements, Heart Rate Variability and Systems Biology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Rationale: The global prevalence of diabetes, along with its devastating effects on life expectancy and quality of life, continues to increase. Worldwide, the total number of people with diabetes is projected to rise from about 171 million in 2000 to 336 million in the year 2030. Type 2 diabetes accounts for about 85 percent to 95 percent of all diagnosed cases of diabetes and is associated with a number of serious long-term complications, which are a major cause of morbidity, hospitalization and mortality in diabetic patients. More evidence is becoming available that both lifestyle and clinical intervention in the pre-diabetic condition are effective in slowing down progression of pre-diabetes to overt diabetes.
Over many centuries, several forms of traditional medicine have developed which are often based on fundamental principles that differ from those of "Western" medicine. One of the most prominent characteristics of Traditional Chinese Medicine (TCM), is a more holistic approach to the functioning and disfunctioning of living organisms. Every healthy organism is in a Yin Yang balance and is considered to be a complex interplay between body and mind. Western medicine relies on detailed classification of diseases, empirical investigations and treatments targeting those disorders. However, "Western medicine" is showing an increased interest in traditional forms of medicine.
Objectives: The primary objective of the present study is to determine consistency in classification of DM type 2 in three categories as defined by Traditional Chinese Medicine (TCM) in pre-diabetic subjects.
Secondary objectives are to find relationships between diagnosis according to TCM and risk profile according to Western approach (fasting glucose and HbA1c in plasma, age, BMI, waist circumference). Another objective is to find relationships between classification of risk for DM type 2 according to TCM and objective parameters.
详细描述
Rationale: The global prevalence of diabetes, along with its devastating effects on life expectancy and quality of life, continues to increase. Worldwide, the total number of people with diabetes is projected to rise from about 171 million in 2000 to 336 million in the year 2030. Type 2 diabetes accounts for about 85 percent to 95 percent of all diagnosed cases of diabetes and is associated with a number of serious long-term complications, which are a major cause of morbidity, hospitalization and mortality in diabetic patients. More evidence is becoming available that both lifestyle and clinical intervention in the pre-diabetic condition are effective in slowing down progression of pre-diabetes to overt diabetes.
Over many centuries, several forms of traditional medicine have developed which are often based on fundamental principles that differ from those of "Western" medicine. One of the most prominent characteristics of Traditional Chinese Medicine (TCM), is a more holistic approach to the functioning and disfunctioning of living organisms. Every healthy organism is in a Yin Yang balance and is considered to be a complex interplay between body and mind. Western medicine relies on detailed classification of diseases, empirical investigations and treatments targeting those disorders. However, "Western medicine" is showing an increased interest in traditional forms of medicine.
The progress in research, especially metabolomics, as the ultimate phenotyping, has been shown to enable the efficacy study of complex mixtures such as Traditional Chinese Medicine (TCM) in complex biological systems, bridging it with molecular pharmacology. The present study is especially designed to explore biomarkers and tools for early diagnosis of diabetes mellitus type 2 with objective Western markers and TCM.
Objectives: The primary objective of the present study is to determine consistency in classification of DM type 2 in three categories as defined by Traditional Chinese Medicine (TCM) in pre-diabetic subjects.
Secondary objectives are to find relationships between diagnosis according to TCM and risk profile according to Western approach (fasting glucose and HbA1c in plasma, age, BMI, waist circumference). Another objective is to find relationships between classification of risk for DM type 2 according to TCM and objective parameters.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy as assessed by the
- •health and lifestyle questionnaire, (P7348 F02; in Dutch)
- •physical examination
- •results of the pre-study laboratory tests
- •Males aged between 30 and 70 years at Day 01 of the study
- •Body Mass Index (BMI) between 26 and ≤ 35 kg/m2
- •Pre-diabetic as established by fasting glucose 6.1 to 6.9 mmol/L
- •Normal Dutch eating habits as assessed by P7348 F02
- •Voluntary participation
- •Having given written informed consent
- •Willing to comply with the study procedures
- •Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- •Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
排除标准
- •Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- •Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- •Having a history of medical or surgical events that may significantly affect the study outcome
- •Medication use
- •Alcohol consumption > 28 units/week
- •Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- •Reported slimming or medically prescribed diet
- •Reported vegan, vegetarian or macrobiotic
- •Acupuncture treatment or use of TCM
- •Recent blood donation (<1 month prior to the start of the study)
- •Not willing to give up blood donation during the study
- •Personnel of TNO Quality of Life, their partner and their first and second degree relatives
- •Not having a general practitioner
- •Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.