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Investigation of the effect of isomaltulose (PalatinoseTM) on metabolic parameters in subjects with Type 2 Diabetes. - ISODIA

Else Kröner-Fresenius-Zentrum für ErnährungsmedizinKlinikum rechts der IsarUptown München Campus D0 个研究点目标入组 110 人开始时间: 2012年1月16日最近更新: 2024年8月19日

适应症

试验速览

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•written informed consent, sex: female or male, age >18 years, BMI 25 – 40 kg/m2, confirmed type 2 diabetes mellitus, diabetes treatment with diet alone or oral antidiabetic agents (insulin secretagogues, metformin, insulin sensitizers, alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors) without changes in the therapy regimen for at least three months prior to study start, HbA1c 6.5 – 9.0 % assessed in the screening visit, usual daily intake of 30-60 g sucrose or sucrose equivalent from sweetened foods or beverages assessed by 3-d dietary records before study start, willingness to regular consumption of test products, preference for sweet food in habitual diet,
•willingness to restrict intake of sweet foods other than the test products, = 3 meals in the habitual diet

•treatment with insulin, presence or history of severe chronic disease, pregnancy and lactation, glucocorticoid therapy, abnormal dietary habits and dislike of sweetened foods.

发起方

Else Kröner-Fresenius-Zentrum für ErnährungsmedizinKlinikum rechts der IsarUptown München Campus D