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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75939563

Enrollment

Registered

2006-12-14

Start date

2002-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type two diabetes in post-menopausal women Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

A tablet containing 66 mg of soy isoflavones or an identical microcrystalline cellulose tablet (placebo) will be given twice daily. The patients will receive either placebo/isoflavone tablet for thre

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
1. Modification of glycaemic parameters 2. Modification of indices of cardiovascular risk	—

Secondary

Measure	Time frame
1. Alteration in renal function 2. Alteration in endogenous sex hormones	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026