Early Diagnosis of Diabetes Mellitus Type 2 (DM2) (7348)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469287
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : April 7, 2008
Netherlands: Ministry of Health, Welfare and Sports
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Brief Summary:

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 or disease
Impaired Blood Glucose Level Overweight Obesity

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
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
Study Start Date : June 2007
Actual Study Completion Date : June 2007

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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy as assessed by the

    • health and lifestyle questionnaire, (P7348 F02; in Dutch)
    • physical examination
    • results of the pre-study laboratory tests
  2. Males aged between 30 and 70 years at Day 01 of the study
  3. Body Mass Index (BMI) between 26 and ≤ 35 kg/m2
  4. Pre-diabetic as established by fasting glucose 6.1 to 6.9 mmol/L
  5. Normal Dutch eating habits as assessed by P7348 F02
  6. Voluntary participation
  7. Having given written informed consent
  8. Willing to comply with the study procedures
  9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
  10. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

  1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
  2. 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
  3. Having a history of medical or surgical events that may significantly affect the study outcome
  4. Medication use
  5. Smoking
  6. Alcohol consumption > 28 units/week
  7. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
  8. Reported slimming or medically prescribed diet
  9. Reported vegan, vegetarian or macrobiotic
  10. Acupuncture treatment or use of TCM
  11. Recent blood donation (<1 month prior to the start of the study)
  12. Not willing to give up blood donation during the study
  13. Personnel of TNO Quality of Life, their partner and their first and second degree relatives
  14. Not having a general practitioner
  15. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00469287

Metabolic ward of TNO Quality of Life
Zeist, Utrecht, Netherlands, 3700AJ
Sponsors and Collaborators
Netherlands: Ministry of Health, Welfare and Sports
Principal Investigator: Wilrike J Pasman, PhD TNO

Responsible Party: Dr. W.J. Pasman, TNO Quality of Life Identifier: NCT00469287     History of Changes
Other Study ID Numbers: P7348
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: April 7, 2008
Last Verified: April 2008

Keywords provided by TNO:
diabetes mellitus
blood sugar
Traditional Chinese medicine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms