No registrations found.
ID
Source
Brief title
Health condition
Diabetes Mellitus, proteinuria, albuminuria, hypertension, kidney disease, dietary sodium, RAAS-blockade
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Albuminuria response;
2. Blood pressure response.
Secondary outcome
Extracellular fluid volume response.
Background summary
N/A
Study objective
To investigate the added effects of dietary sodium restriction and hydrochlorothiazide on top of ACEi, on albuminuria and blood pressure, in patients with diabetic nephropathy, and whether extracellular fluid volume is an intermediate factor in these.
Study design
Patients visit the outpatient clinic every 49th day of each study period for assessment of the endpoints (albuminuria, blood pressure) and safety parameters (potassium, renal function). At the 14th day of each period dietary sodium compliance (urinary sodium excretion) is checked.
Intervention
Combinations of:
1. Lisinopril 40 mg/d;
2. Hydrochlorothiazide 50 mg/d;
3. Normal diet;
4. Sodium restricted diet.
Inclusion criteria
1. Diabetic nephropathy;
2. Diabetes mellitus type II;
3. Proteinuria <3.0 g/24h;
4. Stable creatinine clearance > 30 mL/min;
5. Age 18 years or older.
Exclusion criteria
1. Diabetes mellitus type I;
2. Myocardial infarction or other cardiovascular or cerebrovascular event within the last 3 months prior to entry into the study;
3. Kidney disease other than caused by diabetes mellitus or hypertension;
4. Uncontrollable hypertension after the run- in period (>180/100 mmHg);
5. Serum potassium > 6.0 mmol/L;
6. Incompliance with regard to study medication or diet;
7. Unable to give informed consent;
8. Contraindication for the use of lisinopril or eplerenone.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2240 |
| NTR-old | NTR2366 |
| CCMO | NL20366.042.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35646 |
Summary results
Kwakernaak AJ, Krikken JA, Binnenmars SH, Visser FW, Hemmelder MH, Woittiez AJ, Groen H, Laverman GD, Navis G; Holland Nephrology Study (HONEST) Group.<br>
Lancet Diabetes Endocrinol. 2014 May;2(5):385-95. doi: 10.1016/S2213-8587(14)70030-0. Epub 2014 Mar 5.
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PMID nummer van de plublicatie is: 24795252