Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/11/2006
Date assigned
14/12/2006
Last edited
18/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen L Atkin

ORCID ID

Contact details

Diabetes Centre
HS Brocklehurst Building
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol LREC 11/01/207

Study information

Scientific title

Acronym

Study hypothesis

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

Hull and East Yorkshire Local Ethics Committee, June 2002 (ref: LREC 11/01/207).

Study design

Cross over, double blind, placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Soy isoflavones

Primary outcome measures

1. Modification of glycaemic parameters
2. Modification of indices of cardiovascular risk

Secondary outcome measures

1. Alteration in renal function
2. Alteration in endogenous sex hormones

Overall trial start date

01/07/2002

Overall trial end date

01/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

36

Participant 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)

Recruitment start date

01/07/2002

Recruitment end date

01/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Diabetes Centre
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Hull University (UK)

Sponsor details

Medical Department
Brocklehurst Building
Diabetes Centre
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom

Sponsor type

University/education

Website

http://www.hull.ac.uk/

Funders

Funder type

University/education

Funder name

This trial is internally funded by Hull University, Medical Department, Diabetes and Endocrinology (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17468359

Publication citations

  1. Results

    González S, Jayagopal V, Kilpatrick ES, Chapman T, Atkin SL, Effects of isoflavone dietary supplementation on cardiovascular risk factors in type 2 diabetes., Diabetes Care, 2007, 30, 7, 1871-1873, doi: 10.2337/dc06-1814.

Additional files

Editorial Notes