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临床试验/NCT01070238
NCT01070238已完成1 期

Explorative, Pilot Study With Cross-over Design on the Metabolic Response of Orally Applied Slow Released Carbohydrates in Diabetes Type 2 Patients

University of Giessen2 个研究点 分布在 1 个国家开始时间: 2010年2月17日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
试验地点
2
主要终点
Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose

研究概览

简要总结

The study was conducted

  1. to investigate the superiority of isomaltulose in reduction of postprandial hyperglycemia
  2. to describe the kinetics of glucose absorption after a load of isomaltulose
  3. to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2 diabetic patients.

详细描述

Epidemiological studies have shown that postprandial hyperglycemia is associated with atherosclerotic diseases. Therefore, therapeutic strategies to reduce postprandial hyperglycemia are desirable. An effective way to improve postprandial glucose level is the use of carbohydrates with low glycemic index. Isomaltulose is a reducing disaccharide occurring naturally in honey and sugar cane juice, including products derived thereof. It is an isomer of sucrose and composed of glucose and fructose linked alpha-1,6 instead of alpha-1,2.

Isomaltulose has been reported to be digested more slowly than sucrose. Due to this property, lower and slower increases in blood glucose responses are expected for isomaltulose than sucrose. Early studies have demonstrated attenuated glycemic and insulin responses after isomaltulose ingestion than after sucrose. This study was performed to describe the postprandial glucose metabolism more comprehensively after bolus administration of different doses of isomaltulose compared to sucrose in type 2 diabetic patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis: type 2 diabetes according to WHO/ADA criteria for more than 1 yr
  • Adults aged 18-75 years old
  • HbA1c < 8%, fasting blood glucose < 140 mg/dl
  • For at least 2 months prior to visit 1, subjects must have been on a stable antidiabetic therapy regimen
  • Subjects willing to perform home blood glucose monitoring and to otherwise comply with study protocol requirements

排除标准

  • Type 1 diabetes mellitus
  • Pregnant or lactating women or women planning to become pregnant
  • Women who become pregnant will be withdrawn from the study
  • Clinically significant heart, liver, lung, or kidney disease
  • Drug or alcohol abuse
  • Concomitant therapy with systemic glucocorticoids or acarbose
  • Subjects unable to adhere to instructions during the qualification phase

结局指标

主要结局

Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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