Early Diagnosis of Diabetes Mellitus Type 2 (DM2) (7348)
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Purpose
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.
| Condition |
|---|
|
Impaired Blood Glucose Level Overweight Obesity |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2007 |
| Study Completion Date: | June 2007 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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
Exclusion Criteria:
- 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
- Smoking
- 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.
Contacts and Locations| Netherlands | |
| Metabolic ward of TNO Quality of Life | |
| Zeist, Utrecht, Netherlands, 3700AJ | |
| Principal Investigator: | Wilrike J Pasman, PhD | TNO Quality of Life |
More Information
No publications provided
| Responsible Party: | Dr. W.J. Pasman, TNO Quality of Life |
| ClinicalTrials.gov Identifier: | NCT00469287 History of Changes |
| Other Study ID Numbers: | P7348 |
| Study First Received: | May 2, 2007 |
| Last Updated: | April 4, 2008 |
| Health Authority: | Netherlands: Dutch Health Care Inspectorate |
Keywords provided by TNO Quality of Life:
|
diabetes mellitus blood sugar overweight obesity Traditional Chinese medicine |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Overweight Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Overnutrition Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013