The effect of modest salt reduction on blood pressure and endothelial function in diabetic patients

ISRCTN	ISRCTN41450337
DOI	https://doi.org/10.1186/ISRCTN41450337
Secondary identifying numbers	N0236194367

Submission date: 23/04/2008
Registration date: 23/01/2009
Last edited: 19/07/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rebecca Suckling
Scientific

Blood Pressure Unit
St George's University of London
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom

Email	rsuckling@sgul.ac.uk

Study information

Study design	Randomised cross-over study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of modest salt reduction on blood pressure and endothelial function in diabetic patients: a randomised cross-over study
Study objectives	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(s)	Wandsworth Local Research Ethics Committee, 08/06/2006, ref: 06/Q0803/45
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2006
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St George's University of London

London
SW17 0RE
United Kingdom

Sponsor information

St George's University of London (UK)
Hospital/treatment centre

Cranmer Terrace
Tooting
London
SW17 0RE
England
United Kingdom

Email	sallen@sgul.ac.uk
Website	http://www.sgul.ac.uk/
"ROR"	https://ror.org/040f08y74

Funders

Funder type

Charity

NHS R & D Support Funding (UK)

No information available

Hypertension Trust (UK)
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

19/07/2017: No publications found in PubMed, verifying study status with principal investigator.