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…
ID
Bron
Verkorte titel
Aandoening
Diabetes Mellitus, proteinuria, albuminuria, hypertension, kidney disease, dietary sodium, RAAS-blockade
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Albuminuria response;<br>
2. Blood pressure response.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
Combinations of:
1. Lisinopril 40 mg/d;
2. Hydrochlorothiazide 50 mg/d;
3. Normal diet;
4. Sodium restricted diet.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2240 |
| NTR-old | NTR2366 |
| CCMO | NL20366.042.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35646 |
Samenvatting resultaten
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