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糖尿病診断基準

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糖尿病の分類と診断基準に関する委員会報告

糖尿病診断基準検討委員会

葛谷  健*1※1 中川 昌一*2 佐藤  譲*3 金澤 康徳*4
岩本 安彦*5 小林  正*6 南條 輝志男*7 佐々木 陽*8
清野  裕*9 伊藤千賀子*10 島  健二*11 野中 共平*12
門脇  孝*13※2

※1委員長 ※2幹事

要約:概念:糖尿病は、インスリン作用の不足による慢性高血糖を主徴とし、種々の特徴的な代謝異常を伴う疾患群である。その発症には遺伝因子と環境因子がともに関与する。代謝異常の長期間にわたる持続は特有の合併症を来たしやすく、動脈硬化症をも促進する。代謝異常の程度によって、無症状からケトアシドーシスや昏睡に至る幅広い病態を示す。
分類(Table1,2,Fig.1参照):糖代謝異常の分類は成因分類を主体とし、インスリン作用不足の程度に基づく病態(病期)を併記する。成因は、(I)1型、(II)2型、(III)その他の特定の機序、疾患によるもの、(IV)妊娠糖尿病、に分類する。1型は発症機構として膵β細胞破壊を特徴とする。2型は、インスリン分泌低下とインスリン感受性の低下(インスリン抵抗性)の両者が発症にかかわる。(III)は遺伝素因として遺伝子異常が同定されたものと、他の疾患や病態に伴うものとに大別する。
病態(病期)では、インスリン作用不足によって起こる高血糖の程度や病態に応じて、正常領域、境界領域、糖尿病領域に分ける。糖尿病領域は、インスリン不要、高血糖是正にインスリン必要、生存のためにインスリン必要、に区分する。前2者はインスリン非依存状態、後者はインスリン依存状態と呼ぶ。病態区分は、インスリン作用不足の進行や、治療による改善などで、所属する領域が変化する。詳細は、本文、分類3.糖尿病の分類のための所見を参照されたい。
診断(Table3,4参照):糖代謝異常の判定区分:糖尿病の診断には慢性高血糖の確認が不可欠である。糖代謝の判定区分は、糖尿病型(空腹時血糖値≧126mg/dlまたは75g糖負荷試験(75gOGTT)2時間値≧200mg/dl、あるいは随時血糖値≧200mg/dl)、正常型(空腹時<110mg/dl、かつ2時間値<140mg/dl)、境界型(糖尿病型でも正常型でもないもの)に分ける。これらの基準値は静脈血漿値である。持続的に糖尿病型を示すものを糖尿病と診断する。
境界型はADAやWHOのIFG(impaired fasting glucoseあるいはimpaired fasting glycemia)とIGT(impaired glucose tolerance)とを合わせたものに一致し、糖尿病型に移行する率が高い。境界型は糖尿病特有の合併症は少ないが、動脈硬化症の危険は正常型よりも大きい。

*1 JA塩谷総合病院(〒329-2145 栃木県矢板市富田77)
*2 天使女子短期大学(〒065-0013 北海道札幌市東区北13条東3丁目)
*3 東北大学医学部第三内科(〒980-8574 宮城県仙台市青葉区星陵町1-1)
*4 自治医科大学附属大宮医療センター(〒330-8503 埼玉県大宮市天沼町1-847)
*5 東京女子医科大学糖尿病センター(〒162-8666 東京都新宿区河田町8-1)
*6 富山医科薬科大学第一内科(〒930-0194 富山県富山市杉谷2630)
*7 和歌山県立医科大学第一内科(〒641-8509 和歌山県和歌山市紀三井寺811-1)
*8 大阪府立成人病センター調査部(〒537-8511 大阪府大阪市東成区中道1-3-3)
*9 京都大学医学研究科病態代謝栄養学(〒606-8507 京都府京都市左京区聖護院川原町54)
*10 広島原爆障害対策協議会健康管理センター(〒730-0052広島県広島市中区千田町3-8-6)
*11 徳島大学医学部臨床検査医学(〒770-8503 徳島県徳島市蔵本町3-18-15)
*12 久留米大学医学部内分泌代謝内科(〒830-0011 福岡県久留米市旭町67)
*13 東京大学大学院医学系研究科糖尿病・代謝内科(〒113-8655 東京都文京区本郷7-3-1)


糖尿病42巻5号(1999)

糖尿病の分類と診断基準に関する委員会報告

臨床診断:1. 空腹時血糖値≧126mg/dl、75gOGTT2時間値≧200mg/dl、随時血糖値≧200mg/dlのいずれか(静脈血漿値)が、別の日に行った検査で2回以上確認できれば糖尿病と診断してよい。血糖値がこれらの基準値を超えても1回だけの場合は糖尿病型と呼ぶ
2. 糖尿病型を示し、かつ次のいずれかの条件がみたされた場合は、1回だけの検査でも糖尿病と診断できる。(1)糖尿病の典型的症状(口渇、多飲、多尿、体重減少)の存在、(2)HbA1c≧6.5%、(3)確実な糖尿病網膜症の存在。
3. 過去において上記1. ないし2. の条件がみたされていたことが確認できる場合は、現在の検査結果にかかわらず、糖尿病と診断するか、糖尿病の疑いをもって対応する。
4. 診断が確定しない場合には、患者を追跡し、時期をおいて再検査する。
5. 糖尿病の臨床診断に際しては、糖尿病の有無のみならず、成因分類、代謝異常の程度、合併症などについても把握するよう努める。
疫学調査:糖尿病の頻度推定を目的とする場合は、1回の検査だけによる「糖尿病型」の判定を「糖尿病」と読み替えてもよい。なるべく75gOGTT2時間値≧200mg/dlの基準を用いる。
検診:糖尿病を見逃さないことが重要で、スクリーニングには血糖値をあらわす指標のみならず、家族歴、肥満などの臨床情報も参考にする。
妊娠糖尿病:妊娠糖尿病の定義は「妊娠中に発症、あるいは初めて発見された耐糖能異常」とする。診断基準として日本産科婦人科学会栄養代謝問題委員会(1984)の基準(空腹時≧100mg/dl、75gOGTT1時間値≧180mg/dl、2時間値≧150mg/dlのいずれか2点をみたすもの)を採用する。糖尿病型を呈するものは糖尿病として扱う。スクリーニング検査として、妊娠中の随時血糖≧100mg/dlであれば、糖負荷試験を行うことを勧める。

〔糖尿病42(5):385~404、1999〕

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Abstract

Report of the Committee of Japan Diabetes Society on the Classification and Diagnostic Criteria of Diabetes Mellitus

The Committee of Japan Diabetes Society for the Diagnostic Criteria of Diabetes Mellitus
Takeshi Kuzuya*1※1, Shoichi Nakagawa*2, Jo Satoh*3, Yasunori Kanazawa*4, Yasuhiko
Iwamoto*5, Masashi Kobayashi*6, Kishio Nanjo*7, Akira Sasaki*8, Yutaka Seino*9, Chikako
Ito*10, Kenji Shima*11, Kyohei Nonaka*12 and Takashi Kadowaki*13※2

*1 JA Shioya General Hospital, Tochigi, Japan
*2 Tenshi Junior College, Hokkaido, Japan
*3 Third Department of Internal Medicine, Tohoku University School of Medicine, Miyagi, Japan
*4 Omiya Medical Center, Jichi Medical School, Saitama, Japan
*5 Diabetes Center, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan
*6 First Department of Internal Medicine, Toyama Medical and Pharmaceutical University, Toyama, Japan
*7 First Department of Medicine, Wakayama University of Medical Science, Wakayama, Japan
*8 Department of Epidemiology, Osaka Seijinbyo Center, Osaka, Japan
*9 Department of Metabolism and Clinical Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan
*10 Hiroshima A-Bomb Casualty Council Health Management Center, Hiroshima, Japan
*11 Department of Laboratory Medicine, Tokushima University, Tokushima, Japan
*12 Endocrinology & Metabolism, Kurume University, School of Medicine, Fukuoka, Japan
*13 Department of Metabolic Diseases, Graduate School of Medicine, University of Tokyo, Tokyo, Japan
(※1: chairman, ※2: secretary of the Committee)

In 1995, the Japan Diabetes Society (JDS) appointed the Committee for the Classification and Diagnosis of Diabetes Mellitus. The following report of the Committee was prepared, taking account of the previous reports from JDS (1970 and 1982), opinions of the council members of the JDS, recent reports of the Expert Committee of American Diabetes Association (ADA) and the WHO Consultation, and new data presented at the JDS Symposium on the Classification and Diagnosis of Diabetes Mellitus held in June, 1998.
Concept of diabetes mellitus: Diabetes mellitus is a group of diseases characterized by chronic hyperglycemia and other specific metabolic abnormalities, with heterogenous etiologies in which both genetic and environmental factors are involved. After a long duration of metabolic derangement, specific complications of diabetes (retinopathy, nephropathy and neuropathy) may occur. Arteriosclerosis is also accelerated in the presence of diabetes. Depending on the severity of metabolic abnormality, diabetes may be asymptomatic, may present with characteristic symptoms such as thirst, polyuria, polydipsia, weight loss, or it may progress to ketoacidosis and coma.
Classification(Tables1, 2, Fig1): To describe diabetes and abnormal glucose metabolism, we adopt both etiological classification and staging of pathophysiology due to the degree of deficiency of insulin effect. Etiological classification of diabetes and related disorders of glycemia includes, (1) type1, (2) type2, (3) those due to specific mechanism and diseases, and (4) gestational diabetes mellitus. Type1 is characterized by destructive lesion of β cells due to either autoimmune mechanism or unknown cause. Type2 is characterized by decreased insulin secretion plus decreased insulin sensitivity (insulin resistance). Category (3) includes two subgroups; in subgroup A, genetic susceptibility to diabetes has been identified by DNA analysis, and in subgroup B, diabetes is associated with other pathologic conditions or diseases.
The staging of glucose metabolism includes normal, borderline and diabetic stages. The diabetic stage is further classified into3 substages; non-insulin requiring, insulin-requiring for glycemic control, and insulin-dependent for survival. The former two correspond to the previous NIDDM and the latter to IDDM. In each individual, these stages may vary according to the deterioration of the disease process or the improvement of metabolism, either spontaneously or by treatment.
Diagnosis(Tables3, 4): The confirmation of chronic hyperglycemia is a prerequisite for the diagnosis of diabetes mellitus. The state of glycemia is classified into3 categories; diabetic type, borderline type (or impaired glycemia) and normal type (or normoglycemia). Diabetic type is defined when fasting plasma glucose (FPG) is 126mg/dl or higher, and/or plasma glucose2 hours after 75g glucose load (2hPG) is 200mg/dl or higher. Casual plasma glucose higher than 200mg/dl is also regarded as indicating diabetic type. Normal type is defined when FPG is below 110mg/dl and 2hPG below 140mg/dl. Borderline type (impaired glycemia) is defined in those who belong neither to diabetic nor to normal types. These glycemic cutoff values represent venous plasma glucose levels. The persistence of ‘diabetic type’ in a subject indicates that he or she has diabetes.
The procedure of clinical diagnosis: 1. Diabetes mellitus is diagnosed when hyperglycemia meeting criteria for ‘diabetic type’ is recognized on more than2 occasions examined on separate days. Before confirmation by the second plasma glucose testing, the subject is regarded simply to have ‘diabetic type’.
2. The diagnosis of diabetes can be made by a single plasma glucose test meeting criteria for ‘diabetic type’, when one of the following three conditions exists; (1) the subject has typical symptoms of diabetes mellitus (i. e. thirst, polyuria, polydipsia, weight loss), (2)HbA1c is 6.5% or higher (HbA1c should be determined according to the recommendation of JDS Committee for Standardization of Glycohemoglobin), (3)unequivocal diabetic retinopathy is detected.
3. If the above conditions (i. e. 1. or 2.) existed in the past and were well documented, the subject is to be diagnosed either to have diabetes or suspected of diabetes regardless of the glycemic status at present.
4. If the diagnosis of diabetes cannot be established after the repeated tests of plasma glucose, clinical informations should be evaluated in order to assess the probability of developing diabetes. In such cases, re-testing of plasma glucose after some interval is recommended.
5. At clinical diagnosis, the physician should assess not only the presence or absence of diabetes, but also its etiology and glycemic stage, and the presence of diabetic complications.
Epidemiological aspect: In order to determine the prevalence of diabetes in an epidemiological survey, ‘diabetic type’ may be regarded as ‘diabetes’. The use of 2hPG cutoff level of ≧ 200mg/dl is recommended. If it is difficult, the FPG cutoff level of ≧ 126mg/dl can be used together with the description of criteria used for that survey.
Screening: The most important point is not to overlook ‘diabetes’ at the initial testing. Not only parameters of hyperglycemia, but also clinical informations such as family history, obesity etc, should be included to screen subjects for further testing.
Children and aged people: For children, 1.75g/kg glucose is used instead of 75g (maximum=75g). The cutoff levels for categories of glucose metabolism is the same for children and aged people.
Normal type and borderline type (normo-and impaired glycemia): Only FPG and 2hPG are adopted as cutoff values, but in clinical situations, it is recommended to measure plasma glucose also at 30 and 60 minutes during 75g oral glucose tolerance test (OGTT). It is also recommended to measure insulin levels as well. They help predict the risk of developing diabetes in the future. Among people with ‘normal type’, those with 1hPG higher than 180mg/dl are at higher risk to develop diabetes than those with 1hPG lower than 180mg/dl.
The borderline type in this report corresponds to the sum of impaired fasting glucose or glycemia(IFG) plus impaired glucose tolerance (IGT) by ADA and WHO new recommendations. Subjects in this category are at higher risk to develop diabetes than those with ‘normal type’. Those with low insulinogenic index (the ratio of increment of plasma insulin to that of plasma glucose at 30min of OGTT) are at particularly higher risk to develop diabetes. Diabetes-specific microvascular complications are rare but arteriosclerotic complications are fairly frequent in this category.
Gestational diabetes mellitus (GDM): The current definition of GDM is "any glucose intolerance developed or detected during pregnancy". We adopt the proposal of the Japan Society of Gynecology and Obstetrics for the diagnosis of GDM (1984). GDM is defined when two or more values of the following points at 75g OGTT are higher than the cutoff levels; FPG ≧ 100mg/dl, 1hPG ≧ 180mg/dl and 2hPG ≧ 150mg/dl. As a screening test, casual plasma glucose is to be measured at first visit of pregnancy, and if it exceeds 100mg/dl, the subject should be tested by OGTT. Patients who have had glucose intolerance since pregestational period, and who have been presented as ‘diabetic type’, should be under closer supervision than those who become GDM during pregnancy for the first time.
HbA1c: There is a large overlap in the distribution of HbA1c between groups with ‘normal type’ and ‘borderline type’ and mild ‘diabetic type’. Therefore, HbA1c is not a suitable parameter to detect mild glucose intolerance. As stated before, HbA1c higher than 6.5% suggests diabetes, but HbA1c below 6.5% alone should not be regarded as an evidence against the diagnosis of diabetes.

J. Japan Diab. Soc. 42(5):385~404, 1999

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