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

Not Applicable

Completed

• Conditions: Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Metabolic; Nutritional, Metabolic, Endocrine; Type 2 diabetes

• Registration Number: ISRCTN90604927
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-19
• Study Completion: 2013-12-12
• Last Update Posted: 20 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantify the magnitude

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration