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RAAS-blockade in type II diabetes: added effects of dietary sodum restriction and diuretics.


- candidate number8132
- NTR NumberNTR2366
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2010
- Secondary IDsNL20366.042.08 METC UMCG
- Public TitleRAAS-blockade in type II diabetes: added effects of dietary sodum restriction and diuretics.
- Scientific TitleRAAS-blockade in type II diabetes: added effects of low sodium diet and diuretics.
- ACRONYMDINAMO
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedHypertension, Proteinuria , Diabetes Mellitus, Sodium, Renin-angiotensin-aldosterone system (RAAS), Diet, Albuminuria, Kidney disease
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2009
- planned closingdate1-feb-2012
- Target number of participants55
- InterventionsCombinations of:
1. Lisinopril 40 mg/d;
2. Hydrochlorothiazide 50 mg/d;
3. Normal diet;
4. Sodium restricted diet.
- Primary outcome1. Albuminuria response;
2. Blood pressure response.
- Secondary outcomeExtracellular fluid volume response.
- TimepointsPatients 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.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. G.D. Laverman
- CONTACT for SCIENTIFIC QUERIESDr. G.D. Laverman
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsEffects of sodium restriction and hydrochlorothiazide on RAAS blockade efficacy in diabetic nephropathy: a randomised clinical trial.
Kwakernaak AJ, Krikken JA, Binnenmars SH, Visser FW, Hemmelder MH, Woittiez AJ, Groen H, Laverman GD, Navis G; Holland Nephrology Study (HONEST) Group.
Lancet Diabetes Endocrinol. 2014 May;2(5):385-95. doi: 10.1016/S2213-8587(14)70030-0. Epub 2014 Mar 5.

PMID nummer van de plublicatie is: 24795252
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-jun-2010 - 6-dec-2014


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