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临床试验/NCT03231839
NCT03231839已完成不适用

Identification of Factors Predicting the Success of a Nutritional Intervention to Decrease the Risk of Type 2 Diabetes

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2009年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
2
主要终点
change in glucose metabolism

研究概览

简要总结

This study investigates the influence of red meat and fibers on glucose metabolism and body fat composition in subjects at increased risk for type 2 diabetes.

详细描述

The epidemiologic evidence for increased red meat intake and decreased fiber intake as risk factors for T2D is solid. However, few intervention studies have been performed in order to investigate the role of whole-grain intake or the consumption of red meat in glycemic control and prevention of diabetes, yielding contradicting results. Thus, in order to prove causality, further identify potential underlying mechanisms and be able to improve lifestyle modification programs, we performed a randomized, controlled intervention study over six months. The participants are individuals at increased risk for tyoe 2 diabetes. They were randomised to 3 interventions groups: 1) caloric restriction of 400 kcal/day (control group), 2) caloric restriction plus no red meat consumption 3) caloric restriction and increase in fiber intake. Subjects where thoroughly phenotyped by anthropometric parameters, oral glucose tolerance tests, and MRI measurements of body fat composition and iron content in the liver. In this study, we want to compare the effectiveness of reduced caloric intake only versus reduced caloric intake with an additional modification of diet composition in terms of red meat and fiber consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Individuals at a high risk for Type 2 diabetes:
  • positive family history of type 2 diabetes,
  • presence of metabolic syndrome,
  • body mass index (BMI) > 27 kg/m2,
  • diagnosis of impaired glucose tolerance (IGT)
  • previous diagnosis of gestational diabetes diabetes

排除标准

  • Main exclusion criteria
  • diagnosis of type 1 or 2 diabetes mellitus
  • BMI >45 kg/m²
  • presence of serious illness such as cardiovascular, malignant or psychiatric disease.

研究组 & 干预措施

Caloric restriction (control)

Placebo Comparator

daily reduction of caloric intake aimed at 400 kcal/day

干预措施: Caloric restriction (Behavioral)

No red meat

Active Comparator

daily reduction of caloric intake aimed at 400 kcal/day plus no red meat intake

干预措施: no red meat (Behavioral)

Increased fiber intake

Active Comparator

daily reduction of caloric intake aimed at 400 kcal/day plus increased fiber intake (aim: 40gr/day)

干预措施: Increased fiber intake (Behavioral)

结局指标

主要结局

change in glucose metabolism

时间窗: baseline and six months

glucose metabolism measured during the oral glucose tolerance test (OGTT)

次要结局

  • Insulin secretion(baseline and six months)
  • liver fat(baseline and six months)
  • body composition(baseline and six months)
  • liver iron content(baseline and six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

andreas fritsche

Professor

University Hospital Tuebingen

研究点 (2)

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