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
| ISRCTN | ISRCTN75939563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75939563 |
| Protocol serial number | Protocol LREC 11/01/207 |
| Sponsor | Hull University (UK) |
| Funder | This trial is internally funded by Hull University, Medical Department, Diabetes and Endocrinology (UK) |
- Submission date
- 16/11/2006
- Registration date
- 14/12/2006
- Last edited
- 18/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stephen L Atkin
Scientific
Scientific
Diabetes Centre
HS Brocklehurst Building
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cross over, double blind, placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The prevalence of type two diabetes in the UK is increasingly high. Most women with type two diabetes have an increased risk of cardiovascular diseases due to obesity, estrogen depletion, abnormal lipid profile, and endothelial dysfunction amongst others. Recent studies have suggested that dietary supplementation with soy protein combined with isoflavone have a beneficial effect in both glycaemic control and indices of cardiovascular risk. However, it remains unclear if this effect is due to soy protein or isoflavones. The aim of this study is clarify this. Hypothesis: Isoflavone supplementation alone has beneficial effects on glycaemic control, insulin resistance and cardiovascular risk factors in post-menopausal patients with diet controlled type two diabetes. |
| Ethics approval(s) | Hull and East Yorkshire Local Ethics Committee, June 2002 (ref: LREC 11/01/207). |
| Health condition(s) or problem(s) studied | Type two diabetes in post-menopausal women |
| Intervention | 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 three months and after a period of four weeks washout they receive the other (cross over trial) for a further three months. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Soy isoflavones |
| Primary outcome measure(s) |
1. Modification of glycaemic parameters |
| Key secondary outcome measure(s) |
1. Alteration in renal function |
| Completion date | 01/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 36 |
| Key inclusion criteria | 1. Post-menopausal women (amenorrhoea for at least 12 months) 2. Type two diabetes on diet alone as a form of treatment |
| Key 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) |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 01/03/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Diabetes Centre
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2007 | Yes | No |
