- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01356394
Weight Loss Improves Renal Hemodynamics
18. mai 2011 oppdatert av: Nucleus of Education Interdisciplinary Research and Treatment in Nephrology
Weight Loss Improves Renal Hemodynamics in Patients With Metabolic Syndrome
Metabolic syndrome (MS) is a clustering of risk factors for cardiovascular disease (CVD) such as hypertension, hypertriglyceridemia, low HDL-cholesterol levels, disorders of glucose metabolism, and insulin resistance.
A number of associated conditions are included in the MS spectrum such as abdominal obesity, systemic inflammatory activation, endothelial dysfunction, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome, and microalbuminuria.
As a consequence, the diagnosis of MS identifies patients who are at increased risk for type 2 diabetes mellitus and CVD.
In the last few years, the potential for MS to trigger renal damage and accelerate the progression of pre-existing nephropathy has become a focus of research.
Some studies have suggested that MS can influence the development of CKD, although the underlying mechanisms are not well understood.
In this study, the investigators hypothesized that modifying a key component of the MS, namely obesity, could attenuate renal damage.
The investigators examined the impact of weight loss on creatinine clearance and urinary albumin excretion in non-diabetic obese patients with MS.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Non-diabetic patients with MS were recruited from an outpatient clinic at the Division of Nephrology of the Federal University of Juiz de Fora, Brazil.
MS was defined according to the criteria of the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATPIII).
The study was divided into two phases: phase 1 (baseline) and phase 2 (intervention).
At the first study visit, a full medical history was taken and a clinical examination was performed.
Blood samples were taken to determine plasma glucose levels, both after fasting and 2 h after a 75-g oral glucose overload (oral glucose tolerance test; OGTT), as well as levels of plasma insulin, creatinine, total cholesterol, HDL-cholesterol, triglycerides, and uric acid.
At visit 2, the preliminary results were evaluated and urine samples were collected in duplicate for measurement of microalbuminuria.
Creatinine clearance was estimated using the Cockcroft-Gault formula, corrected for body surface area.
The subjects were kept free of any medication (statins, antihypertensive, and anti-inflammatory drugs) over the entire study period.
The only medications allowed during the study were analgesics such as dipyrone and hioscin.
At visit 3, each patient was evaluated by a registered dietitian with expertise in medical nutrition therapy with the aim of achieving a weight loss of at least 5% from baseline.
Patients were commenced on a 12-week calorie-restricted diet consisting of 50% carbohydrate, 20-25% protein, and 25-30% fat.
The patients were evaluated by the dietitian every 2 weeks.
At the final visit all laboratory tests were repeated.
At the end of phase 2, patients were divided into two groups: responders, who had achieved at least a 5% reduction in body weight and non-responders, who had not achieved the target weight reduction.
Studietype
Intervensjonell
Registrering (Faktiske)
58
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Minas Gerais
-
Juiz de Fora, Minas Gerais, Brasil, 36036-330
- NIEPEN
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male and female
- Age: 20 to 65 years old
- Metabolic syndrome according to the criteria of the National Cholesterol Education Program Adult Treatment Panel III
Exclusion Criteria:
- fasting plasma glucose > 126 mg/dL or a history of diabetes mellitus
- hypertension stage 2 or 3
- glomerulonephritis
- CKD stages 3, 4, or 5
- severe heart or lung disease
- pregnancy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Renal Hemodynamics
Tidsramme: 12 weeks
|
Hemodynamics renal parameters, namely, creatinine clearance and urinary albumin excretion were measured before and after twelve weeks on a calorie restricted diet.
|
12 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Rogerio B de Paula, PhD, Professor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2010
Primær fullføring (Faktiske)
1. desember 2010
Studiet fullført (Faktiske)
1. februar 2011
Datoer for studieregistrering
Først innsendt
11. mai 2011
Først innsendt som oppfylte QC-kriteriene
18. mai 2011
Først lagt ut (Anslag)
19. mai 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. mai 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mai 2011
Sist bekreftet
1. januar 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 273/2006
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på dietary intervention
-
Rush University Medical CenterUniversity of Chicago; National Institute on Aging (NIA); Advocate Hospital...RekrutteringSlag | Demens | Alzheimers sykdom | Demens, vaskulær | Kognitiv nedgangForente stater
-
The Hong Kong Polytechnic UniversityRekruttering
-
Beth Israel Deaconess Medical CenterFullførtFasting | Ketogen diett | Metabolsk reguleringForente stater
-
Thomas Jefferson UniversityRekrutteringProstata karsinomForente stater
-
Oregon Research InstituteFullført
-
Sarah BlaylockVA Office of Research and DevelopmentFullførtFalle | LavsynForente stater
-
Tel Aviv UniversityFullført
-
Thomas Jefferson UniversityFullførtHematopoetisk og lymfoid celle-neoplasma | Ondartet fast neoplasmaForente stater
-
University Hospital, BonnGerman Federal Ministry of Education and ResearchUkjent