Phytoestrogen dietary supplementation in post-menopausal women with type two diabetes: effects on glycaemic control, insulin resistance and indices of cardiovascular risk. A cross over trial

Completed

• Conditions: Type two diabetes in post-menopausal women; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN75939563
• Lead Sponsor: Hull University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

1. Post-menopausal women (amenorrhoea for at least 12 months)
2. Type two diabetes on diet alone as a form of treatment

Exclusion Criteria

1. Secondary causes of impaired glucose tolerance such as hypercortisolemia
2. No hormone replacement or stopped at least six weeks prior recruitment
3. Uncontrolled hypothyroidism (if receiving thyroid hormone replacement, the patient should be euthyroid with Thyroid Stimulating Hormones [TSH] less than 5.0 mU/L)
4. Blood pressure more than 160/90 mmHg
5. Recent initiation of statin treatment/dose modification (less than four weeks)
6. Patients not wishing to allow disclosure to General Practitioners (GPs)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Modification of glycaemic parameters<br>2. Modification of indices of cardiovascular risk

Secondary Outcome Measures

Name	Time	Method
1. Alteration in renal function<br>2. Alteration in endogenous sex hormones