- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02799719
Body Fat Mass Association With Clinical Metabolic Profiles, Markers of Inflammation and Adipocytokines
Body Fat Mass as Predictors of Survival in Hemodialysis Patients and Its Association With Clinical Metabolic Profiles, Markers of Inflammation and Adipocytokines in Chronic Hemodialysis Patients: a Prospective Study.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Patient Selection
Clinically stable stage 5 chronic kidney disease patients (400 patients) attending the Tungs Taichung Metroharbour will be enrolled in this study. These patients will be given written information and are invited to participate in the study. Written informed consent will be obtained from each patient enrolled. Our hospital dialysis center undergoes multi-frequency bioelectrical impedance analysis( BIA) scanning on a bimonthly basis as part of their ongoing clinical care. Multi-frequency BIA is performed on patients attending the center as part of their routine dry weight assessment. Among these patients, eighty ambulatory adults attending for thrice-weekly outpatient hemodialysis treatments concomitantly had similar dual-energy X-ray absorptiometry (DEXA) scan and postdialysis multi-frequency BIA assessments for review. Patients with implantable defibrillators, those with cardiac pacemakers, and amputees are excluded from the study. This study will be conducted prospectively for 3 years.
Methods Body Composition Assessment Measurements with dual-energy X-ray absorptiometry (DEXA)
DEXA was performed with patients in the supine position. The radiation exposure is estimated to be one tenth of that for standard chest radiography. DEXA is scheduled postdialysis. Whole-body composition, including total and segmental lean, total body fat mass, and bone mineral content, will be calculated using the compatible software. For patients with multiple multifrequency BIA estimations, the study performed will be arranged temporally to the DEXA scan for more relevant comparison.
Measurement of Bioimpedance In all patients BIS will be carried out bimonthly using the Body Composition Monitor (Fresenius Medical Care Deutschland Gesellschaft mit beschrankter Haftung (GmbH), Germany), which takes measurements at 50 frequencies in a range of 5 to 1000 kilohertz(KHz). The measurement was performed approximately 30 minutes after the midweek hemodialysis session, with four conventional electrodes being placed in the patient, who was lying in the supine position: two in the hand and two in the foot contralateral to the vascular access. Regarding the quality of measurements, all exceeded 95%. The manufacturer of the Body Composition Monitor (Fresenius Medical Care) indicated that 30 minutes after the hemodialysis session, the balance between intra-and extracellular fluid was restored and no significant differences in relation to pre-dialysis values were observed. Parameters obtain directly through BIS that are used in this study are free fat mass, lean body mass, intracellular water (ICW) and extracellular water( ECW). Protein-energy wasting (PEW), represented by the intracellular water/dry body weight (ICW/BW) ratio, and overhydration, represented by the extracellular water/dry body weight(ECW/BW) ratio will be analysed.
Anthropometric parameters The following data will collected bimonthly : height (m)), dry weight (kg) measured with a calibrated scale and body mass index(BMI,kg/m2). Abdominal obesity is defined as a waist circumference of >80 cm in women and >90 cm in men.
Biochemical assays and other measurements Fasting blood samples (4 ml each time) were taken just before starting a dialysis session.The vacutainers were kept cold and placed immediately on ice, then they were centrifuged at 4 degree centigrade and the serum was stored at -80 degree centigrade until the analysis. The measurements of serum creatinine, cholesterol, total proteins, albumin, prealbumin and carbon dioxide(CO2) were analysed using standard methods. Urea reduction ratio and single-pool dialysis efficiency calculator(Kt/V) were used to represent the administered dialysis treatment dose. To decrease intraindividual variation, 3-month averaged values for laboratory measures and urea reduction ratio during the study calendar quarter were calculated and used in this study. High sensitivity C- reactive proteins(CRP) was obtained by the immuno-turbidimetric method. Serum 25(OH)D3 was measured by enzymeimmunoassay and the levels of intact parathyroid hormone( i-PTH) were assessed using immunoradiometric assay. Plasma insulin levels were measured using a radioimmunoassay method. Interleukin-6(IL-6) and tumor necrosis factor-alpha (TNF-α) concentrations were measured in duplicate by enzyme-linked immunosorbent assay(ELISA). Insulin resistance was assessed using the following validated formula: homeostasis model assessment of insulin resistance (HOMA-IR)=(fasting glucose [mmol/1] × fasting insulin [μU/ml])/22.5. Because of confounding introduced by exogenous insulin administration to HOMA-IR results, HOMA-IR was only measured in patients who were not treated with insulin . All the above measurements will be done at baseline, and the end of each years (4 times for the whole study)
Studietype
Inschrijving (Werkelijk)
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Both sexes aged > 20 years-old. Received stable hemodialysis at least 3 months. Written informed consent.
Exclusion Criteria:
- Patients with malignant disease, acute infectious disease, acute inflammatory disease (such as collagen disease), and advanced liver disease are excluded.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Occurence of CVD events
Tijdsspanne: 3 years
|
A DEXA scan is used to measure total and segmental lean(kg), total body fat mass(kg), and bone mineral content(kg). A BIS is used to measurefree fat mass(Kg), lean body mass(Kg),ICW(L) and ECW(L). |
3 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Correlates of metabolic syndrome
Tijdsspanne: 3 years
|
The measurements of cholesterol(mg/dl),albumin(mg/dl) ,plasma insulin levels(mU/L) were measured using a radioimmunoassay method.
Insulin resistance was assessed using the following validated formula: homeostasis model assessment of insulin resistance (HOMA-IR)=(fasting glucose [mmol/1] × fasting insulin [μU/ml])/22.5
|
3 years
|
Presence of inflammation
Tijdsspanne: 3 years
|
Various biomarkers such as CRP, IL-6, TNF-a
|
3 years
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 102047
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Overgewicht en obesitas
-
Swansea UniversityVoltooidA Bite of ACT' (BOA) Acceptance and Commitment Therapy Online cursus psycho-educatie | Een wachtlijstcontroleVerenigd Koninkrijk
-
University of SheffieldMid Yorkshire Hospitals NHS TrustIngetrokkenObesitas, Acceptance and Commitment Therapy, Weight Management ServiceVerenigd Koninkrijk
-
Bambino Gesù Hospital and Research InstituteVoltooidErnstige pediatrische obesitas (BMI > 97° pc -Volgens Centers for Disease Control and Prevention BMI Charts-) | Veranderde leverfunctietesten | Glykemische intolerantieItalië
-
Alexandria UniversityVoltooidAcceptance and Commitment Therapy, geestelijke gezondheid, cognitieve stoornissen, colorectale kankerEgypte