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- Essai clinique NCT01635062
The VALIDATE-D Study (VALIDATE-D)
Evaluating Hormonal Mechanisms for Vitamin D Receptor Agonist Therapy in Diabetes: The VALIDATE-D Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study aims to evaluate whether vitamin D receptor agonist therapy (calcitriol) in diabetes lowers renin-angiotensin system (RAS) activity in a manner similar to an ACE inhibitor. This is a physiology study, focused on evaluating hormonal changes in the circulating and tissue RAS when compared to placebo.
Subjects with type 2 diabetes and obesity and normal kidney function will undergo evaluation of their circulating and renal-vascular RAS activity and urinary protein at baseline, after withdrawing interfering medications, while on a controlled electrolyte diet, and in controlled posture settings. They will then randomly receive a study medication (calcitriol or placebo) for 3 weeks followed by a re-assessment of their RAS parameters. The main outcomes that will be evaluated following calcitriol/placebo include measures of the circulating renin activity (primary), as well as measures of the renal-vascular RAS (renal plasma flow) and urine protein (secondary)
The primary outcome is the change in the plasma renin activity when sodium restricted, before and after intervention. Secondary outcomes include the change in renal plasma flow and urine protein when sodium loaded, before and after intervention.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Type-Two Diabetes (treated with diet alone, with oral hypoglycemic agents, or with a single injection of basal insulin daily)
- Normal blood pressure, or Mild (Stage 1) Hypertension that is either untreated, or adequately treated with a single anti-hypertensive drug.
- Age >18 years and <70 years
- Estimated GFR > 60ml/min
- Normal laboratory values for: Complete blood count, sodium, potassium, glucose, liver enzymes, urinalysis
- Electrocardiogram without any signs of prior infarction, ventricular conduction abnormality, or supraventricular arrhythmia.
Exclusion Criteria:
- Chronic Kidney Disease or eGFR<60
- History of nephrolithiasis (kidney stones)
- Multiple (more than one) insulin injections daily (since insulin can alter the RAS)
- Poorly controlled type 2 diabetes (That may require more aggressive therapy) as defined by an HbA1c>8.5%
- Type 1 diabetes
- Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
- Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs by a physician.
- The use of prescribed doses of potassium supplements.
- History of liver failure
- History of parathyroid or granulomatous disorders
- History of heart failure, cerebrovascular disease or coronary heart disease
- History of known microvascular complications of diabetes (including retinopathy, neuropathy, nephropathy)
- Illness requiring overnight hospitalization in the past 6 months
- Active tobacco or recreational drug use
- Pregnancy or current breast feeding
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: calcitriol
Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.
|
Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks.
Autres noms:
|
Comparateur placebo: placebo
Subjects will receive placebo for 3 weeks.
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Subjects will receive placebo for 3 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy
Délai: baseline and 2 weeks following calcitriol/placebo therapy
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The below results represent the change in Plasma Renin Activity.
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baseline and 2 weeks following calcitriol/placebo therapy
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Renal Plasma Flow After Calcitriol/Placebo Therapy
Délai: baseline and 3 weeks following calcitriol/placebo therapy
|
Subjects had their renal plasma flow assessed at baseline while sodium loaded, and again after 3 weeks of randomized therapy with either calcitriol (up to 0.75 mcg daily) or placebo.
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baseline and 3 weeks following calcitriol/placebo therapy
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Change in Urine Protein After Calcitriol/Placebo Therapy
Délai: baseline and 3 weeks following calcitriol/placebo therapy
|
Subjects have their urine protein assessed at baseline while sodium loaded and again 3 weeks after randomized therapy with calcitriol or placebo.
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baseline and 3 weeks following calcitriol/placebo therapy
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Micronutriments
- Modulateurs de transport membranaire
- Vitamines
- Agents de conservation de la densité osseuse
- Hormones et agents régulateurs du calcium
- Agents vasoconstricteurs
- Agonistes des canaux calciques
- Calcitriol
- Dihydroxycholécalciférols
Autres numéros d'identification d'étude
- 2012P000905
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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