Early Diagnosis of Diabetes Mellitus Type 2 (DM2) - Full Text View

Sponsors and Collaborators:	TNO Quality of Life Netherlands: Ministry of Health, Welfare and Sports
Information provided by:	TNO Quality of Life
ClinicalTrials.gov Identifier:	NCT00469287

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

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

Further study details as provided by TNO Quality of Life:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469287

Locations

Netherlands, Utrecht
Metabolic ward of TNO Quality of Life
Zeist, Utrecht, Netherlands, 3700AJ

Sponsors and Collaborators

TNO Quality of Life

Netherlands: Ministry of Health, Welfare and Sports

Investigators

Principal Investigator:

Wilrike J Pasman, PhD

TNO Quality of Life

More Information

Responsible Party:	TNO Quality of Life ( Dr. W.J. Pasman )
Study ID Numbers:	P7348
Study First Received:	May 2, 2007
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00469287
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by TNO Quality of Life:

diabetes mellitus
blood sugar
overweight
obesity
Traditional Chinese medicine

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009