Condition category
Circulatory System
Date applied
23/04/2008
Date assigned
23/01/2009
Last edited
29/04/2015
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

Dr Rebecca Suckling

ORCID ID

Contact details

Blood Pressure Unit
St George's University of London
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom
-
rsuckling@sgul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236194367

Study information

Scientific title

The effect of modest salt reduction on blood pressure and endothelial function in diabetic patients: a randomised cross-over study

Acronym

Study hypothesis

We propose that a moderate reduction in salt intake will improve blood pressure, endothelial function and damage to target organs without affecting insulin sensitivity.

Ethics approval

Wandsworth Local Research Ethics Committee, 08/06/2006, ref: 06/Q0803/45

Study design

Randomised cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular disease

Intervention

Individuals will have an initial two-week run-in period where dietary salt advice is given to achieve a salt reduction of 6 g. They are then randomised by computer-generated random allocation to either placebo or salt 6 g daily for six weeks in matched tablets. Both the study participants and the investigators are blinded. There is no washout period. At the end of the study, individuals are seen at 2 - 4 weeks for a follow up visit.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Casual systolic and diastolic blood pressure. Primary outcomes are measured at baseline and weeks 2, 5, 8, 11 and 14.

Secondary outcome measures

1. Urinary albumin excretion
2. Ambulatory blood pressure monitoring (ABPM)
3. Endothelial function
4. Arterial stiffness

Secondary outcomes are measured at baseline and weeks 8 and 14.

Overall trial start date

01/10/2006

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 30 to 80 years, either sex
2. Untreated blood pressure of greater than 120/70 mmHg with impaired glucose tolerance on oral glucose tolerance test or diet controlled type two diabetes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
2. Type two diabetes on oral hypoglycaemic agents or insulin
3. Secondary hypertension
4. Uncontrolled heart failure or active ischaemic heart disease
5. Active malignancy or liver disease
6. Females who are pregnant, breast feeding or taking the oral contraceptive pill
7. Individuals started on lipid lowering therapy within the last three months

Recruitment start date

01/10/2006

Recruitment end date

01/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's University of London
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's University of London (UK)

Sponsor details

Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom
-
sallen@sgul.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.sgul.ac.uk/

Funders

Funder type

Charity

Funder name

NHS R & D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hypertension Trust (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes