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Effects of miglitol on visceral fat distribution and cardiovascular risk factors in subjects with the metabolic syndrome

基本情報

進捗状況	試験終了
対象疾患	Metabolic syndrome
試験開始日（予定日）	2006-07-01
目標症例数	2
臨床研究実施国	日本
研究のタイプ	介入

試験の内容

介入1	Life-style modification
介入2	Miglitol-treatment and Life-style modification
主要アウトカム評価項目	Changes in visceral fat distribution and cardiovascular risk factors
副次アウトカム評価項目

対象疾患

年齢（下限）
年齢（上限）
性別	3
選択基準	Metabolic syndrome (IDF criteria). In the IDF criteria, subjects to be defined as metabolic syndrome have: abdominal obesity (modified Japanese criteria, waist circumference >=90 cm in men and >=80 cm in women), plus any two of the following four factors; 1) hypertriglyceridemia (serum triglyceride concentration >=150 mg/dl [1.69 mmol/l]); 2) low HDL cholesterol (serum HDL cholesterol concentration <40 mg/dl [1.04 mmol/l] in men and <50 mg/dl [1.29 mmol/l] in women); 3) elevated blood pressure: systolic blood pressure >=130 mmHg and/or diastolic blood pressure >=85 mmHg; 4) high fasting glucose: serum glucose concentration >=100 mg/dl (5.6 mmol/l).
除外基準	Patients with a history of cardiovascular or cerebrovascular disease, hepatic or renal disease, diabetes mellitus or heavy smoker were excluded.