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临床试验/ISRCTN90604927
ISRCTN90604927已完成未知

A double-blind placebo-controlled parallel trial of soy phytoestrogens in patients with type 2 diabetes and borderline low testosterone levels

Hull and East Yorkshire Hospitals NHS Trust (UK)0 个研究点目标入组 200 人开始时间: 2010年5月19日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
200

研究概览

简要总结

  1. 2017 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5684229/ 2. 2018 results relating to effect on thyroid hormone levels in https://www.ncbi.nlm.nih.gov/pubmed/30524380 3. 2019 follow-up analysis in: https://www.ncbi.nlm.nih.gov/pubmed/31031706

研究设计

研究类型
Interventional

入排标准

性别
Male

入选标准

  • 1. Diagnosis of type 2 diabetes
  • 2. Patients will be on stable medication for their diabetes, hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study
  • 3. Age between 45 - 75 years at the start of the study, male only
  • 4. Serum testosterone value of 12 nmol/L or less (normal range 1236 nmol/L) and who are symptom free will be eligible to participate

排除标准

  • 1. Patients with concurrent illness or any medication in the last 3 months
  • 2. Patients not wishing to allow disclosure to their GPs
  • 3. Patients who are taking hormone replacement therapy
  • 4. Patients who are currently or have taken antibiotics in the last 3 months
  • 5. Hba1c at recruiting stage of greater than 9%
  • 6. Vegetarians
  • 7. Smokers
  • 8. Patients with known food allergies

研究者

发起方
Hull and East Yorkshire Hospitals NHS Trust (UK)

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