WO2010103585A1 - Procédé pour évaluer un syndrome métabolique ou une maladie associée à celui-ci - Google Patents

Procédé pour évaluer un syndrome métabolique ou une maladie associée à celui-ci Download PDF

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Publication number
WO2010103585A1
WO2010103585A1 PCT/JP2009/005508 JP2009005508W WO2010103585A1 WO 2010103585 A1 WO2010103585 A1 WO 2010103585A1 JP 2009005508 W JP2009005508 W JP 2009005508W WO 2010103585 A1 WO2010103585 A1 WO 2010103585A1
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WIPO (PCT)
Prior art keywords
metabolic syndrome
value
constituent
index
risk
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PCT/JP2009/005508
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English (en)
Japanese (ja)
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横田充弘
谷村大輔
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Yokota Mitsuhiro
Tanimura Daisuke
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Application filed by Yokota Mitsuhiro, Tanimura Daisuke filed Critical Yokota Mitsuhiro
Priority to JP2011503572A priority Critical patent/JPWO2010103585A1/ja
Publication of WO2010103585A1 publication Critical patent/WO2010103585A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575—Hormones
    • G01N2333/62—Insulins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/04—Endocrine or metabolic disorders

Definitions

  • the present invention relates to a method for evaluating the morbidity or risk of developing metabolic syndrome or its constituent diseases (diabetes, hypertension, hyperlipidemia, arteriosclerosis).
  • This application claims priority based on Japanese Patent Application No. 2009-54314 filed on Mar. 8, 2009, the entire contents of which are incorporated by reference.
  • Non-patent Document 1 Metabolic syndrome includes not only insulin resistance but also pathological conditions related to obesity such as oxidative stress (Non-patent Document 2) and adipose tissue hypoxia (Non-patent Document 3). It is an incentive for curing.
  • Adiponectin is secreted from adipocytes, and its blood concentration decreases with obesity and increases with obesity improvement. Therefore, it is regarded as an indicator of metabolic syndrome.
  • Various studies to date have shown that adiponectin concentration decreases in the state of metabolic syndrome (Non-Patent Document 4), and the relationship between hypoadiponectinemia and cardiovascular disease has also been reported (Non-patent Document 4). Reference 5).
  • HOMA-IR Homeostasis assessment-Insulin Resistance
  • HOMA-IR is one of the indicators that have been conceived for easily examining the presence or absence of the underlying insulin resistance (Non-Patent Document 6), and fasting insulin value ( ⁇ U / ml) x fasting blood glucose It is expressed as value (mg / dl) / 405.
  • HOMA-IR is said to show a good correlation with the value of insulin resistance measured by the glucose clamp method, but it cannot always be a good index in hyperglycemia and non-obese individuals (Non-patent Document 7).
  • Patent Document 1 a method for evaluating insulin resistance using a fasting insulin value, a fasting blood glucose level, and an adiponectin value has been proposed (Patent Document 1). According to this method, an evaluation result highly correlated with the conventional glucose clamp method is obtained.
  • an object of the present invention is to find a new index (marker) useful for evaluating the morbidity or risk of developing metabolic syndrome or its constituent diseases, and to meet these demands.
  • the present inventors paid attention to blood adiponectin concentration and HOMA-IR, and analyzed the relationship between these indices and metabolic syndrome using a large-scale population. As a result, it was found that the value obtained by dividing the blood adiponectin concentration by HOMA-IR complements the characteristics of both blood adiponectin concentration and HOMA-IR, and can comprehensively evaluate the morbidity of metabolic syndrome. Moreover, it was shown that the said value is useful in predicting the risk of developing metabolic syndrome. Based on these findings, the following inventions are provided.
  • the present invention provides a new index (marker) useful for evaluating metabolic syndrome or its constituent diseases.
  • “Metabolic syndrome” refers to a condition in which insulin resistance, arteriosclerosis-induced lipoprotein abnormality, and hypertension are combined based on the accumulation of obesity and visceral fat, resulting in an increased risk of cardiovascular disease.
  • the diagnostic criteria for metabolic syndrome are shown below. Unless otherwise specified, the International Diabetes Federation (IDF) standard is preferentially applied in this specification. The reason for this is that there is a debate about the determination of the abdominal circumference with respect to Japanese standards by eight academic societies such as the Japan Society of Internal Medicine (Oka R, Reassessment of the cutoff values of waist circumference and visceral fat area for identifying Japanese subjects at risk for the metabolic syndrome.
  • IDF International Diabetes Federation
  • the constituent diseases refer to diabetes, hypertension, hyperlipidemia or arteriosclerosis.
  • Atherosclerosis includes cerebral arteriosclerosis and coronary atherosclerosis.
  • index of the present invention is obtained by dividing the blood adiponectin concentration by a value obtained by multiplying a fasting insulin value and a fasting blood glucose level, and the following formula ( Hereinafter, it is also expressed as “the mathematical formula of the present invention”).
  • / represents division. Blood adiponectin concentration / (fasting insulin value ⁇ fasting blood glucose level) ⁇ C
  • C is a constant.
  • the constant C is not particularly limited, but preferably the constant C is a positive or negative integer in order to facilitate calculation.
  • a specific example of the constant C in this case is 1.
  • the constant C can be set to 405.
  • the above equation can be expressed as follows using HOMA-IR which is an index of insulin resistance. Blood adiponectin concentration / HOMA-IR
  • the units of blood adiponectin concentration, fasting insulin level, and fasting blood glucose level are not particularly limited.
  • the unit of blood adiponectin concentration is ⁇ g / mL
  • the unit of fasting insulin value is ⁇ U / ml
  • the unit of fasting blood glucose level is mg / dl.
  • the first aspect of the present invention provides a method for evaluating the morbidity of metabolic syndrome or its constituent diseases using the value given by the mathematical formula of the present invention as an index. “Evaluating the morbidity of the metabolic syndrome or its constituent diseases” means grasping the possibility or probability of suffering from these diseases. Therefore, when the method of the present invention is carried out, for example, evaluation / determination results such as low, high, and moderate possibility of suffering from the target disease are obtained. The result is very useful because it is not only an opportunity to receive a medical examination but also an opportunity to review lifestyle habits. Note that the evaluation / determination here can be automatically / mechanically performed irrespective of the judgment of a person having specialized knowledge such as a doctor or a laboratory technician, as is apparent from the judgment criteria.
  • the index of the present invention is useful not only for evaluating metabolic syndrome but also for evaluating the morbidity of its constituent diseases.
  • the index of the present invention is used to comprehensively evaluate the morbidity of metabolic syndrome. Used to do. That is, in this embodiment, metabolic syndrome is the target disease.
  • the value of the index of the present invention is low, the possibility of suffering from metabolic syndrome or a constituent disease thereof is high, and the value of the index of the present invention is high. This is less likely. Therefore, as a result of obtaining the value of the index of the present invention for the subject, it can be determined that the possibility of morbidity is high if the value is low, and conversely, if the value is high, morbidity is possible It can be determined that the property is low. In order to perform more accurate and useful determination, it is preferable to set a plurality of groups having different morbidity and associate the range of the index value of the present invention for each group. An example is shown below.
  • Group 1 (highly likely to be affected): index value ⁇ a Group 2 (moderately morbid): a ⁇ index value ⁇ b Group 3 (low possibility of morbidity): b ⁇ index value
  • Boundary values for dividing groups should be derived from the results of a large-scale analysis for a large number of subjects including those with metabolic syndrome, as in the analysis described in the examples below. Can do.
  • An example of the boundary value derived from the results of the examples described later (example divided into four groups) is as follows. In this example, “blood adiponectin concentration / HOMA-IR” is adopted as an index. (For men) Group 1 (very likely to be affected): index value ⁇ about 9 Group 2 (highly likely to be affected): about 9 ⁇ index value ⁇ about 13 Group 3 (low chance of morbidity): about 13 ⁇ index value ⁇ about 18 Group 4 (very unlikely): approx. 18 ⁇ indicator value
  • Group 1 (very likely to be affected): index value ⁇ about 7
  • Group 2 (highly likely to be affected): about 7 ⁇ index value ⁇ about 13
  • Group 3 (low chance of morbidity): about 13 ⁇ index value ⁇ about 27
  • Group 4 (very unlikely): approx. 27 ⁇ indicator value
  • a method for evaluating the risk of developing metabolic syndrome or its constituent diseases using the value given by the mathematical formula of the present invention as an index.
  • “Evaluating the onset risk of metabolic syndrome or its constituent diseases” means grasping the risk (susceptibility) of developing these diseases in the future.
  • the risk of developing these diseases is determined, and preparation for future onset can be made. That is, important and meaningful suggestions are given from a preventive medical standpoint.
  • the evaluation / determination here can be automatically / mechanically performed irrespective of the judgment of a person having specialized knowledge such as a doctor or a laboratory technician, as is apparent from the judgment criteria.
  • the value of the index of the present invention is low, the risk of developing metabolic syndrome or a constituent disease thereof increases, and if the value of the index of the present invention is high, the same onset occurs. Risk is low. Therefore, as a result of obtaining the value of the index of the present invention for the subject, it can be determined that the onset risk is high if the value is low, and on the contrary, if the value is high, the onset risk is low. Can be determined. As in the case of the first aspect, in order to make more accurate and useful determination, a plurality of groups with different onset risks are set, and the ranges of the index values of the present invention are associated with each group. Good.
  • the index value of the present invention it is advisable to obtain the index value of the present invention over time (preferably periodically) and examine the variation. If it seems to change at a low value, it can be determined that the possibility of developing the disease in the future (ie, the risk of onset) is high. On the other hand, if it changes at a high value, it is usually determined that the onset risk is low. On the other hand, when a decrease in value is recognized, it can be considered that the risk of onset has increased. In this case, in addition to the determination result that the risk of onset is high, it is possible to promote improvement of lifestyle habits. As is clear from this example, it is extremely useful to examine the index value of the present invention over time and grasp the fluctuation, because it can give an opportunity to review the lifestyle and improve it.
  • first aspect the possibility of suffering from the metabolic syndrome or its constituent diseases (first aspect) or the risk of future onset (second aspect) is not evaluated by focusing on one but comprehensive It is also possible to evaluate the risk, ie the risk for metabolic syndrome or its constituent diseases.
  • Blood adiponectin concentration in a blood sample is referred to as “blood adiponectin concentration”.
  • blood adiponectin concentration is used as an expression encompassing the term “whole blood adiponectin concentration”, the term “plasma adiponectin concentration” and the term “serum adiponectin concentration”.
  • the blood adiponectin concentration is not limited to this, but is preferably measured using an immunological technique.
  • the immunological technique the adiponectin concentration can be measured quickly and with high sensitivity. Also, the operation is simple.
  • a substance having a specific binding property to adiponectin is used.
  • an anti-adiponectin antibody is usually used.
  • any substance that has a specific binding property to adiponectin and can measure the amount of the adiponectin can be used without being limited to the anti-adiponectin antibody.
  • ELISA enzyme immunoassay: Enzyme -Linked Immuno Sorbent Assay
  • Another RIA method radioimmunoassay Radio Immuno Assay
  • human adiponectin measurement kits based on the latex agglutination method for example, Latex turbidometric immunassay (Otsuka Pharmaceutical) have become widespread, and such kits may be used to measure the adiponectin concentration.
  • the measurement of fasting insulin level and fasting blood glucose level may be performed by a conventional method.
  • methods for measuring fasting insulin levels include EIA (enzyme immunoassay: EnzymezyImmuno Assay) and IRMA (immunoradiometric assay: Immuno Radio Metric Assay).
  • EIA enzyme immunoassay: EnzymezyImmuno Assay
  • IRMA immunoradiometric assay: Immuno Radio Metric Assay
  • hexonase G-6-PDH method, electrode method, and glucose dehydrogenase method can be exemplified as a method for measuring fasting blood glucose level.
  • the scope of application of the present invention is not limited to Japanese. That is, the present invention can be applied to non-Japanese mongoloids and other races (such as cocaside). However, the present invention is particularly effective for a Japanese or a population genetically close to a Japanese (for example, a Chinese population or a Korean population is close to a Japanese population). Therefore, the subject in the present invention is preferably a Mongoloid (Japanese, Chinese, Korean, etc.), more preferably a Japanese.
  • NCT 00262691 is a prospective study of cardiovascular disease that started in 2004 and targeted 3975 Japanese general population (1712 men, 2263 women) over the age of 50. It is intended only for those who give explanations to the general residents of Kitanagoya City at the time of a health checkup and obtain consent. Blood was collected in all cases, and 3297 people (1456 men and 1841 women) who measured blood adiponectin concentration and blood insulin concentration were analyzed. As a diagnostic standard for metabolic syndrome, the International Diabetes Society (IDF) standard (Non-patent Document 8) was adopted.
  • IDF International Diabetes Society
  • adiponectin / HOMA-IR remains younger than 50 years if adiponectin / HOMA-IR remains below 9.3 for men and 6.7 for women.
  • adiponectin / HOMA-IR is useful as an index for risk assessment of metabolic syndrome.
  • the present invention provides a novel indicator for metabolic syndrome or its constituent diseases.
  • the index By using the index, it is possible to evaluate the morbidity of the metabolic syndrome or its constituent diseases and the risk of developing these diseases in the future. Evaluation of the onset risk is extremely useful from the standpoint of preventive medicine, as it is an opportunity to encourage early consultation and an opportunity to review and improve lifestyle habits.

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Abstract

L'invention concerne une nouvelle mesure (marqueur) utilisée pour évaluer un syndrome métabolique ou une maladie associée à celui-ci. L'état d'un patient souffrant d'un syndrome métabolique ou d'une maladie associée à celui-ci ou de risque de syndrome métabolique ou de maladie associée à celui-ci peut être évalué par utilisation, en tant que mesure, d'une valeur calculée à partir de la formule suivante : (niveau adiponectine sanguine)/[(indice d'insuline à jeun)×(niveau de glucose sanguin à jeun)]×C ("/" signifiant une division et "C" représentant une constante).
PCT/JP2009/005508 2009-03-08 2009-10-21 Procédé pour évaluer un syndrome métabolique ou une maladie associée à celui-ci WO2010103585A1 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017161105A1 (fr) * 2016-03-16 2017-09-21 True Health Ip Llc Procédés de traitement d'une altération de la tolérance au glucose et/ou d'une réduction de la sécrétion d'insuline
WO2020043601A1 (fr) * 2018-08-27 2020-03-05 F. Hoffmann-La Roche Ag Méthode de vérification des performances d'un dispositif de culture

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JP2006098100A (ja) * 2004-09-28 2006-04-13 Otsuka Pharmaceut Co Ltd インスリン抵抗性の評価方法
JP2008536474A (ja) * 2004-12-09 2008-09-11 パーレジェン・サイエンシズ・インク． メタボリックシンドローム、肥満及びインスリン抵抗性のマーカー
WO2008123567A1 (fr) * 2007-03-27 2008-10-16 Skylight Biotech Inc. Procédé de détermination du degré de risque et/ou de l'évolution d'un syndrome métabolique

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JP4485981B2 (ja) * 2005-03-29 2010-06-23 株式会社いかがく メタボリックシンドロームの予知検査方法およびそれに用いるキット
EP2053395A4 (fr) * 2006-08-04 2010-04-21 Ajinomoto Kk Procédé d'évaluation de syndrome métabolique, appareil d'évaluation de syndrome métabolique, système d'évaluation de syndrome métabolique, programme d'évaluation de syndrome metabolique et support d'enregistrement, et procede de recherche de substance ayant un effet prophylactique /de soulagement
JP4912182B2 (ja) * 2007-02-23 2012-04-11 東ソー株式会社 イオン交換クロマトグラフィーによる血液中のカイロミクロン（ｃｍ）の分離方法、および、メタボリックシンドロームの識別方法
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Publication number Priority date Publication date Assignee Title
JP2006098100A (ja) * 2004-09-28 2006-04-13 Otsuka Pharmaceut Co Ltd インスリン抵抗性の評価方法
JP2008536474A (ja) * 2004-12-09 2008-09-11 パーレジェン・サイエンシズ・インク． メタボリックシンドローム、肥満及びインスリン抵抗性のマーカー
WO2008123567A1 (fr) * 2007-03-27 2008-10-16 Skylight Biotech Inc. Procédé de détermination du degré de risque et/ou de l'évolution d'un syndrome métabolique

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SU ET AL.: "'Metabolic Syndrome no Shuyo Inshiril de aru Insulin Teikosei Oyobi Ko Nyosan Kessho to Himan no Kanren", THE JAPANESE JOURNAL OF CONSTITUTIONAL MEDICINE, vol. 70, no. 1, 2008, pages 16 - 22 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017161105A1 (fr) * 2016-03-16 2017-09-21 True Health Ip Llc Procédés de traitement d'une altération de la tolérance au glucose et/ou d'une réduction de la sécrétion d'insuline
WO2020043601A1 (fr) * 2018-08-27 2020-03-05 F. Hoffmann-La Roche Ag Méthode de vérification des performances d'un dispositif de culture
CN112639478A (zh) * 2018-08-27 2021-04-09 豪夫迈·罗氏有限公司 用于验证培养装置性能的方法

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