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Clinical Trials/ISRCTN90604927
ISRCTN90604927
Completed
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 sites200 target enrollmentMay 19, 2010
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ConditionsTopic: Diabetes Research NetworkSubtopic: Type 2Disease: MetabolicNutritional, Metabolic, EndocrineType 2 diabetes

Overview

Phase
未知
Intervention
Not specified
Conditions
Topic: Diabetes Research Network
Sponsor
Hull and East Yorkshire Hospitals NHS Trust (UK)
Enrollment
200
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

  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
Registry
who.int
Start Date
May 19, 2010
End Date
December 12, 2013
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Hull and East Yorkshire Hospitals NHS Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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