The effect of modest salt reduction on blood pressure and endothelial function in diabetic patients
| ISRCTN | ISRCTN41450337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41450337 |
| Protocol serial number | N0236194367 |
| Sponsor | St George's University of London (UK) |
| Funders | NHS R & D Support Funding (UK), Hypertension Trust (UK) |
- 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
Scientific
Blood Pressure Unit
St George's University of London
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom
| rsuckling@sgul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised cross-over study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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(s) |
Casual systolic and diastolic blood pressure. Primary outcomes are measured at baseline and weeks 2, 5, 8, 11 and 14. |
| Key secondary outcome measure(s) |
1. Urinary albumin excretion |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
St George's University of London
London
SW17 0RE
United Kingdom
SW17 0RE
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/07/2017: No publications found in PubMed, verifying study status with principal investigator.
