Impaired Blood Glucose Level7348NCT00469287
Early Diagnosis of Diabetes Mellitus Type 2 (DM2)
An observational study of Impaired Blood Glucose Level and Overweight, run by TNO at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Impaired Blood Glucose Level, Overweight, Obesity
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2007to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Metabolic ward of TNO Quality of Life
Zeist, Utrecht, 3700AJ
About this study
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
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.
Read more
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.
Read the detailed description
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.
Study design: This study is designed as an explorative study. Study population: In the study 50 pre-diabetic male volunteers, with a fasting blood glucose ≥ 6.1 and ≤ 6.9 mmol/L, 30-70 years old, and having a BMI ≥ 26 and ≤ 35 kg/m2 will participate.
Intervention: No administration of a study substance will take place.
Main study parameters/endpoints:
TCM Diagnosis:Identification of DM type 2 based on TCM, diagnosed independently by 3 physicians and classified in Upper Xiao, Middle Xiao and Lower Xiao.
General measurements as BMI, waist circumference, blood pressure and heart rate variability will be conducted.
Next to these measurements also the following parameters will be established. Biophoton emission: a recording of the energy field and balance based on analysis of intensity and quantum stochastic nature of light from both hands (ventral and dorsum), in combination with both right-left and dorsal-ventral symmetry of both hands.
Performance Meridian Measurements (MERID measurements): The 'MERID' meridian method is based on the change of skin impedance after a given IR (infrared) stimulus to a Biological Active Point (BAP) which gives a reliable and reproducible measure for the energy status of that particular meridian and consequently of the related organ or organ system.
Heart rate variability:
Heart rate is affected by both sympathetic and parasympathetic input. These two branches of the autonomic control system affect both heart rate and changes in heart rate. Cardiac autonomic balance, also called sympatho-vagal balance, is the combined effect of parasympathetic (inhibitory) and sympathetic (excitatory) innervation of the heart and can be considered the main determinant of the regulation of heart rate and can be quantified by means of electrocardiography (ECG) measurements and spectral analysis.
Metabolomics:
Metabolomics to be applied in this study consists of a number of methods based on LC-MS and GC-MS technology to determine (relative) concentrations of endogenous metabolites in biological samples (blood and urine).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This study is set up as a study with an explorative character. No administration of substances will take place. All subjects will be subjected to seven non-invasive measurements, filling in a number of questionnaires and subjected to three physical examinations. Blood sampling, in the fasting state, will be done at two determined time points (pre-study and in study) and will not exceed 30 mL. Furthermore, one (spot) urine sample will be collected in the study.
Based on the above mentioned assessments and the fact that no administration of substances will take place, the discomfort for the subjects in the study is minimal and the risk for participating subjects is negligible.
- Conditions
- Impaired Blood Glucose Level, Overweight, Obesity
- Keywords
- diabetes mellitus, blood sugar, overweight, obesity, Traditional Chinese medicine
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Blood Glucose LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Investigators
- Wilrike J Pasman, PhD, Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469287
- Sponsor's protocol ID
- P7348
- Acronym
- 7348
- Status last verified
- Apr 2008
- First submitted
- 2 May 2007
- Last updated
- 7 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00469287
- Acronym / sponsor ID
- 7348 / P7348
- Conditions
- Impaired Blood Glucose Level, Overweight, Obesity
- Keywords
- diabetes mellitus, blood sugar, overweight, obesity, Traditional Chinese medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- Jun 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 4 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design: This study is designed as an explorative study. Study population: In the study 50 pre-diabetic male volunteers, with a fasting blood glucose ≥ 6.1 and ≤ 6.9 mmol/L, 30-70 years old, and having a BMI ≥ 26 and ≤ 35 kg/m2 will participate.
Intervention: No administration of a study substance will take place.
Main study parameters/endpoints:
TCM Diagnosis:Identification of DM type 2 based on TCM, diagnosed independently by 3 physicians and classified in Upper Xiao, Middle Xiao and Lower Xiao.
General measurements as BMI, waist circumference, blood pressure and heart rate variability will be conducted.
Next to these measurements also the following parameters will be established. Biophoton emission: a recording of the energy field and balance based on analysis of intensity and quantum stochastic nature of light from both hands (ventral and dorsum), in combination with both right-left and dorsal-ventral symmetry of both hands.
Performance Meridian Measurements (MERID measurements): The 'MERID' meridian method is based on the change of skin impedance after a given IR (infrared) stimulus to a Biological Active Point (BAP) which gives a reliable and reproducible measure for the energy status of that particular meridian and consequently of the related organ or organ system.
Heart rate variability:
Heart rate is affected by both sympathetic and parasympathetic input. These two branches of the autonomic control system affect both heart rate and changes in heart rate. Cardiac autonomic balance, also called sympatho-vagal balance, is the combined effect of parasympathetic (inhibitory) and sympathetic (excitatory) innervation of the heart and can be considered the main determinant of the regulation of heart rate and can be quantified by means of electrocardiography (ECG) measurements and spectral analysis.
Metabolomics:
Metabolomics to be applied in this study consists of a number of methods based on LC-MS and GC-MS technology to determine (relative) concentrations of endogenous metabolites in biological samples (blood and urine).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This study is set up as a study with an explorative character. No administration of substances will take place. All subjects will be subjected to seven non-invasive measurements, filling in a number of questionnaires and subjected to three physical examinations. Blood sampling, in the fasting state, will be done at two determined time points (pre-study and in study) and will not exceed 30 mL. Furthermore, one (spot) urine sample will be collected in the study.
Based on the above mentioned assessments and the fact that no administration of substances will take place, the discomfort for the subjects in the study is minimal and the risk for participating subjects is negligible.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy as assessed by the
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2008.
Related trials for Impaired Blood Glucose Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilrike J Pasman, PhD principal investigator
TNO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Blood Glucose Level and Overweight, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2008.