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临床试验/ACTRN12619001676101
ACTRN12619001676101尚未招募未知

The association between a modified carbohydrate diet, quality of life and glycaemic control in Australian adults with type 1 diabetes mellitus: A pilot study

Gold Coast University Hospital0 个研究点目标入组 23 人开始时间: 2019年11月29日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
23

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
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1. Male, female or unspecified gender;
  • 2. 18 years of age or over;
  • 3. Type 1 diabetes for equal to or greater than 1 year from diagnosis date and
  • 4. Individuals who administer insulin using multiple daily injections.

排除标准

  • 1. Patients with type 2 diabetes mellitus;
  • 2. Patients with gestational diabetes mellitus;
  • 3. Presence of a known food allergy or intolerance that may affect the participants’ health or adherence during the intervention;
  • 4. History of an eating disorder;
  • 5. BMI <18.5kg/m2;
  • 6. BMI >25.0kg/m2;
  • 7. Age <18 years;
  • 8. An active medical problem that may hinder the persons’ ability to take part or potentially affect study outcomes e.g. a recent myocardial infarction, stroke or peripheral re-vasularisation (within 3 months), active treatment of diabetic retinopathy, recent serious infection (requiring in-hospital treatment or prolonged antibiotic therapy), active mental health complaint or other active medical problems determined by medical staff;
  • 9. Pregnancy or expectation of conceiving. Participants will be withdrawn at any stage from the study if pregnancy occurs;
  • 10. The use of medications that may affect body weight/body composition (including but not limited to phentermine and corticosteroids);
  • 11. Those for whom the written materials may be unsuitable such as vision impaired or illiterate individuals;
  • 12. Those unable to understand English;
  • 13. Those who failed to provide informed consent and
  • 14. Those who administer insulin using a CSII.

研究者

发起方
Gold Coast University Hospital

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