- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00581269
Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease
The oxidative stress and inflammatory state is known to contribute to the pathogenesis of atherosclerosis, and is predictive of cardiovascular events and mortality rates in the general population and patients with chronic kidney disease (CKD), particularly in patients with end stage renal disease (ESRD) on dialysis therapy 1. Increased oxidative stress and inflammation has been identified in all stages of CKD, ranging from moderate renal insufficiency to ESRD. However, the pathophysiology of increased oxidative stress and inflammation associated with the development of CKD is currently poorly understood.
There is also concern about the epidemic of obesity in the United States, as the overall health status of the general population is adversely affected by increasing adiposity. Recent studies indicate a strong relationship between adiposity and incident CKD. Furthermore, the presence of an elevated body mass index (BMI) is an independent predictor for progression to ESRD, even after additional adjustments for baseline blood pressure and the presence or absence of diabetes mellitus. Limited data in the general population show that healthy lifestyle interventions, such as exercise and dietary caloric restriction, either alone or in combination, reduce the inflammatory and oxidative stress burden seen in obese subjects. The impact of healthy lifestyle modifications on inflammation and oxidative stress has not been investigated in the obese CKD population. Based on the foregoing observations, the purpose of this investigation will be to determine whether healthy lifestyle interventions in the form of low-impact aerobic exercise and dietary calorie restriction in obese subjects (BMI ≥ 30kg/m2) with moderate to severe (Stage III-IV) CKD [estimated glomerular filtration rate (GFR) 20-59 ml/min] will improve oxidative stress, inflammation, insulin resistance, adipocytokines, endothelial dysfunction, and quality of life.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Tennessee
-
Nashville, Tennessee, États-Unis, 37232
- Vanderbilt University Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with Stage III-IV (estimated GFR 20-59 min/ml) chronic kidney disease measured by MDRD formula.
- BMI ≥ 30 kg/m2
- Age > 18 or < 65 years.
- Life expectancy greater than one year.
- Ability to understand and provide informed consent for participation in the study.
Exclusion Criteria:
- Active inflammatory disease such as: AIDS (HIV seropositivity is not an exclusion criteria), active hepatitis C or B, active gout, other active inflammatory diseases.
- Active malignancy excluding basal or squamous cell carcinoma of the skin.
- Patients suffering from Type I Diabetes Mellitus
- Patients with reduced daily caloric intake at baseline (≤ 2000 kcal/day) or malnutrition.
- Patients who are already on a consistent and rigorous exercise regimen.
- Gastrointestinal dysfunction requiring parental nutrition.
- History of functional kidney transplant < 6 months prior to study entry.
- Anticipated live donor kidney transplant over study duration.
- Patients taking anti-inflammatory medication except aspirin < 325mg/day over the past 30 days.
- Patients taking Vitamin E supplements > 60 IU/day, vitamin C > 500mg/day over the past 30days.
- Patients taking any prednisone therapy.
- Hospital admission within the last 30 days.
- On experimental drug protocols.
- Significant cardiac or vascular disease (symptomatic disease; CV event(s) within the last year; significant occlusive atherosclerotic disease or ischemic disease on non-invasive or invasive diagnostic procedures).
- Significant physical disability or immobility (joint disease, joint replacement, muscular disorders).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 1
low-impact aerobic exercise group
|
subjects will undergo supervised physical activity for a maximum of 30-60 minutes, every other day, 3 days per week for 3 months; to offer variety in the exercise prescription, subjects will alternately use a treadmill, an elliptical trainer, a Nu-Step cross-trainer and a recumbent stationary bicycle
|
Comparateur actif: 2
dietary restriction group
|
subjects will undergo a 20% reduction in total daily calories from their usual daily energy consumption every day for 3 months
|
Aucune intervention: 3
control group
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
a statistically significant decrease in plasma F2-isoprostanes, a specific oxidative stress marker
Délai: 3 months
|
3 months
|
a statistically significant decrease in hs-CRP, a specific inflammatory marker
Délai: 3 months
|
3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
significant changes in additional markers of oxidative stress and inflammation
Délai: 3 months
|
3 months
|
significant changes in insulin resistance and adipocytokines
Délai: 3 months
|
3 months
|
a significant improvement in endothelial function as measured by brachial artery FMD
Délai: 3 months
|
3 months
|
a significant improvement in quality of life scores
Délai: 3 months
|
3 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Alp Ikizler, MD, Vanderbilt University Medical Center
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 (Estimation)
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
Autres numéros d'identification d'étude
- 070990
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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