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临床试验/ACTRN12608000206325
ACTRN12608000206325招募中4 期

A randomised study to evaluate High protein diets and resistance exercise training in type 2 diabetes study 2008

Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition0 个研究点目标入组 100 人开始时间: 2008年4月17日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • Male or female
  • Age between 18-65 years
  • BMI (body mass index) not greater than 40 or less than 27 (calculated for the volunteers by the research staff based on weight (kg) divided by height (m) squared)
  • Have type 2 diabetes (HbA1c < 7.0% or previously diagnosed and controlled with medication)
  • Not have type 1 diabetes
  • Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent
  • No abnormality of clinical significance on medical history
  • If female, not pregnant or breast feeding

排除标准

  • BMI(body mass index) greater than 40 or less than 27
  • Not have type 2 diabetes (HbA1c < 7.0% or not previously diagnosed and controlled with medication)
  • Lactose Intolerant
  • Taking Insulin medication
  • Have been previously diagnosed with proteinuria, a malignancy, or metabolic disease such as liver, kidney, respiratory, gastrointestinal disease or stroke, or are pregnant or lactating
  • Have been previously diagnosed with cardiac disease, including myocardial ischemia or major heart rhythm abnormalities.
  • Have high uncontrolled hypertension (resting recumbent BP >160/100 mmHg)
  • Have a musculoskeletal injury, joint or peripheral vascular disease sufficient to impede exercise (such as hip arthritis, foot, ankle problems or pain)
  • Have severe exercise-induced asthma
  • History of smoking during 6 months prior to study
  • History of heavy alcohol consumption (> 5 STD drinks/day)
  • Volunteer unable to cease alcohol consumption for study duration
  • Participated in regular aerobic or resistance exercise program (greater than two 30-min sessions of moderate/vigorous aerobic exercise per week or greater than 1 moderate intensity resistance exercise session per week) during the 6 months prior to study
  • Widely fluctuating exercise patterns
  • Currently on a weight reducing diet
  • Unwilling to be randomized to either experimental group
  • Extended absences due to travel or other commitments
  • Unable to comprehend or cope with study requirements
  • Unable to eat pork and ham on 4 occasions per week
  • Unwilling to be randomised to a non-exercise arm

研究者

发起方
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition

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