- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02805543
The Correlation Between the Retrobulbar Hemodynamics and Intrarenal Hemodynamics in T2DM Patients During the Early Period
Objective: The main target of this study was to research the early changes of retrobulbar and intrarenal hemodynamics, then to research the correlation between them in type 2 diabetes (T2DM) patients without diabetic kidney disease (DKD) and diabetic retinopathy (DR).
Method: 35 T2DM patients (diabetes group) without vascular complications and 30 healthy people (control group) were recruited to research the early changes of renal function, retrobulbar and intrarenal hemodynamics, and then to research the correlation between them. The primary endpoints were the intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic; the secondary endpoints were the retrobulbar hemodynamics RI in the bilateral central retinal artery (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA) were evaluated using color doppler imaging (CDI); the tertiary endpoints were the biochemical endpoints: blood-fat (TC, HDL-C, LDL-C, and TG), FPG, 2hPG, HbA1c, and renal function parameters (BUN, Cr, and GFR); in addition, the albumin excrete rate (AER), urinary albumin/creatinine ratio (UACR) were measured.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association ;
- No smoking history, pulmonary disease, cold, nor pulmonary infection within a fortnight;
- Did not have hepatopathy, nephropathy, hyperuricemia, and gastrointestinal disease; and
- Likely to have good compliance and able to visit our hospital for periodic assessments.
Exclusion Criteria:
- T1DM, gestation and lactation;
- Renal inadequacy,hypohepatia,and heart failure;
- Intensive care with insulin treatment;
- The patients combined with DR and hypertension (antihypertensive drugs were used);
- Patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or intraocular surgery;
- The patients combinated with DKD;
- Patients with other renal conditions that could affect the blood flow, such as urolithiasis, urinary infection, and renal cyst (diameter > 3 cm);
- Cholesterol-lowering drugs can not control the blood-fat (TC > 250 mg/dl, HDL-C < 30 mg/dL, LDL-C > 170 mg/dl, TG > 200 mg/dl) adequately.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
diabetes group
34 T2DM patients without vascular complications as diabetes group
|
|
control group
32 healthy people were recruited as control group
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Intrarenal hemodynamic (bilateral kidney RI) in bilateral interlobular renal arteries were evaluated using Doppler Sonographic in 34 patients
Délai: 3 weeks
|
RI(resistivity index)
|
3 weeks
|
Retrobulbar RI in the bilateral Retrobulbar artery were evaluated using color doppler imaging (CDI) in 34 patients
Délai: 3 weeks
|
RI(resistivity index),Retrobulbar artery[central retinal artery (CRA), posterior ciliary artery (PCA), and arteria ophthalmica (OA)]
|
3 weeks
|
The correlation between the bilateral retrobulbar RI and bilateral kidney RI in 34 patients
Délai: 3 weeks
|
RI(resistivity index)
|
3 weeks
|
Collaborateurs et enquêteurs
Parrainer
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
- 20160204
- F11-262-9-25 (Natural Science Foundation of Shenyang)
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 .
Essais cliniques sur Diabète sucré, Type 2
-
Bnai Zion Medical CenterInconnue
-
Jiangsu HengRui Medicine Co., Ltd.Complété
-
Asahi Kasei Pharma CorporationRecrutement
-
University of MinnesotaActif, ne recrute pasHypoglycémie | Diabète sucré de type 2États-Unis
-
University of Campania "Luigi Vanvitelli"ComplétéDiabète sucré de type 2Italie
-
University of LiverpoolAstraZeneca; Clinical Practice Research DatalinkActif, ne recrute pas
-
Regor Pharmaceuticals Inc.RésiliéDiabète sucré de type 2États-Unis
-
Charles Drew University of Medicine and ScienceNational Center for Research Resources (NCRR)Résilié
-
Population Health Research InstituteNovo Nordisk A/SComplétéDiabète sucré de type 2Canada
-
Northwell HealthPatient-Centered Outcomes Research InstituteComplétéDiabète sucré de type 2 | Diabète de type 2États-Unis
Essais cliniques sur Color doppler imaging
-
PsiOxus Therapeutics LtdComplétéCancer du côlon résécable | Cancer du poumon non à petites cellules résécable | Cancer de la vessie résécable | Carcinome à cellules rénales résécableEspagne
-
Medical Centre LeeuwardenUniversity of Groningen; LIMIS DevelopmentRecrutement
-
Augere Medical ASOslo University Hospital; Sahlgrenska University Hospital, SwedenComplété
-
Queen Mary University of LondonRecrutement
-
French Cardiology SocietyInstitut National de la Santé Et de la Recherche Médicale, FranceComplétéInsuffisance cardiaque diastoliqueFrance
-
JSR Medical Co., Ltd.RecrutementCancer colorectal | Chirurgie colorectale | Rectale/AnaleÉtats-Unis
-
GE HealthcareUniversity Hospital, ZürichComplétéMaladies cardiovasculairesSuisse
-
University of LeipzigInconnue
-
Institut BergoniéComplétéCancer moyen et inférieur du rectumFrance
-
RenJi HospitalRecrutementDébit cardiaqueChine