Zie Engelse samenvattingObjectives: Primary objective•To determine consistency in classification of DM type 2 in three categories as defined by Traditional Chinese Medicine (TCM) in pre-diabetic subjectsSecondary objectives•To find relationships…
ID
Bron
Verkorte titel
Aandoening
- Glucosemetabolismestoornissen (incl. diabetes mellitus)
- Diabetescomplicaties
Synoniemen aandoening
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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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. Diagnosis
will be considered consistent when 80% of the subjects are assigned to the same
category by each physician. In case subjects are classified differently, then
each subject will be evaluated by the three physicians together, and will then
finally be reclassified.
Other measurements:
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 based on analysis of intensity of both hands
(ventral and dorsum) quantum stochastic nature, in combination with both
right-left and dorsal-ventral symmetry of the energy field and balance 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. The sympathetic
and parasympathetic activities have different effects on the frequency
spectrum. High frequencies (>0.15 Hz) are mostly affected by parasympathetic
activity, whereas lower frequencies are affected by both sympathetic and
parasympathetic activity. Heart rate frequency spectra are divided into three
spectral bands: Low frequency: 0.02 - 0.06 Hz (related to temperature
regulation);
Mid frequency: 0.07 - 0.14 Hz (related to resonance of vasomotor control); High
frequency: 0.15 - 0.50 Hz (related to respiratory activity). During the study
ECG will be recorder in every single subject for 30 minutes in semi-supine
position. ECG*s will be amplified, filtered and digitally recorded on a
dedicated data acquisition system. The sampling frequency will be 512 Hz.
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). Based on the
results of the TCM classification, a selection will be made for the samples
(subjects) to be evaluated and the specific fields of interest for metabolomics
will be further identified. Subsequently, the metabolomics methods available
will be evaluated with respect to their suitability to this specific interests
Secundaire uitkomstmaten
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None
Achtergrond van het onderzoek
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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. Important starting points are the five
element (phase) theory and the principle that every healthy organism is in a
Yin Yang balance and is considered to be a complex interplay between body and
mind. Although, Western medicine relies on detailed classification of diseases,
empirical investigations and treatments targeting those disorders, still it 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. The diagnostic views derived from classical TCM will be bridged with
biochemical fingerprints (metabolomics) to enable the possibility to develop
early diagnosis, specifically of DM type 2, an area which is not covered by
Western approaches so far.
In the present study the non-invasive technologies that will be explored as
system readout will be based on: meridian-measurements (infrared), biophoton
emission and heart rate variability (HRV). Integration of Western and TCM
knowledge could be a break-through in (early) diagnosis of DM type 2.
Doel van het onderzoek
Zie Engelse samenvatting
Objectives:
Primary objective
•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
•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)
•To find relationships between classification of risk for DM type 2 according
to TCM and objective parameters (Biophoton, Infrared, HRV, Systems biomarkers)
Onderzoeksopzet
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Study design:
This study is designed as an explorative study
Inschatting van belasting en risico
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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 two minimal 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 20mL. Furthermore, one (spot) urine sample will be collected in
the study.
Based on the abovementioned non-invasive 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.
Publiek
Postbus 360
3700 AJ
Nederland
Wetenschappelijk
Postbus 360
3700 AJ
Nederland
Landen waar het onderzoek wordt uitgevoerd
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Man: >30 en <70 jaar
Bloed glucose levels: >6.1 en < 6.9 mmol/L
BMI: >26 en < 35 kg/m2
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Medicijn gebruik (Westerse of Chinese)
Roken,
Alcohol consumptie: meer dan 28 glazen per week
(Afval) dieet volgend
Vegetarisch, veganist of macrobioot
Acupuncturistische behandeling ondergaand
Opzet
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| Register | ID |
|---|---|
| CCMO | NL17038.028.07 |