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
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