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临床试验/NCT02569684
NCT02569684已完成不适用

Effects of Prebiotics on GLP-1 in Type 2 Diabetes

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebo

研究概览

简要总结

The aim of the study is to compare the effects of prebiotics versus placebo on blood concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.

详细描述

We looked at 6 weeks supplementation with a prebiotic fibre mix of inulin and FOS. Cross over design compared to maltodextrin as placebo. Additional outcome measures: blood glucose, insulin, GLP-2, ghrelin, PYY and leptin after a standardized mixed meal test. Also measured changes in microbiota composition and SCFA in feces before and after intervention/placebo periods, and subjective measures of appetite.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • diabetes type 2
  • BMI 18,5 - 40
  • Not medicated with insulin, GLP-1 analogues or DPP4 inhibitors
  • Moderate intake of alcohol
  • Not excessive exercise
  • Less than 3 kg weight change the last two months
  • Intake of less than 30 g dietary fiber per day

排除标准

  • Coeliac disease
  • Have used antibiotics within the last two months
  • Have used supplements with prebiotics or probiotics the last two months
  • Pregnancy

结局指标

主要结局

Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebo

时间窗: six weeks

The changes in GLP-1 response to either prebiotic fibers or placebo will be compared in a cross-over manner where the participants are their own controls. In between the intervention periods there will be a wash-out period of 4 weeks.

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne-Marie Aas

Associate professor

Oslo University Hospital

研究点 (2)

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