- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00989339
Effects of Intralipid Versus Olive Oil Infusions on Endothelial Function, Immune Function, Inflammatory Markers
Effects of Intralipid and Olive Oil Infusion on Endothelial Function, Inflammatory Markers, Oxidative Stress, Immune Function, Autonomic Nervous System, Insulin Sensitivity and Carbohydrate Metabolism
Recent evidence suggests that increased levels of a circulation fat (free fatty acids or FFAs) can cause high blood pressure and cardiac complications. Intralipid is the only type of fat approved by the FDA for clinical use. It is usually used as nutrition support in malnourished patients. The investigators' preliminary studies indicate that Intralipid results in a significant rise in blood pressure, blood vessel stiffness, and inflammation in obese subjects. Olive oil can also be used as nutrition support. The effect of olive oil intravenous (IV) on blood pressure and inflammation is not known. In this study, the investigators will compare the effect of Intralipid and olive oil on blood pressure, blood vessel stiffness and inflammation in healthy subjects. The investigators hypothesize that Olive oil emulsions will result in less vascular changes and less inflammatory response than Intralipid solutions. Accordingly, the investigators propose a systematic evaluation of the effects of Intralipid, olive oil and normal saline on blood pressure, endothelial function (vascular stiffness), inflammation in normal subjects.
A group of obese subjects will be admitted to the Clinical Research Center on 3 occasions. Subjects will receive repeated infusions of Intralipid, ClinOleic, and normal saline at 20 ml/hour for 24 hours.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Fase 2
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy males or females
- BMI 25 -35 kg/m2, between the ages of 18 and 65 years
- BP < 140/80 mm Hg and no prior history of hypertension
Exclusion Criteria:
- Pregnancy or breast feeding
- History of diabetes, hypertension, fasting triglyceride levels > 250 mg/dL, liver disease (ALT 2.5x > upper limit of normal), serum creatinine ≥ 1.5 mg/dL, -Smokers or ex-smoker < 3 months of cessation, drug or alcohol abuse
- Mental condition rendering the subject unable to understand the scope and possible consequences of the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Twenty-four Hour TPN and Saline Infusion
Subjects will be admitted to the Grady research center on the evening before each study.
The next morning, after an overnight fast, they will receive, in random order, Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr.
The interval between admissions will be 1 month.
|
Infusion of Intralipid 20%, ClinOleic 20% or normal saline at 20 ml/hr for 24 hr.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
endothelial function
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
oxidative stress
Tidsramme: 1 year
|
1 year
|
autonomic nervous system
Tidsramme: 1 year
|
1 year
|
insulin sensitivity
Tidsramme: 1 year
|
1 year
|
carbohydrate metabolism
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00019153
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Forhøjet blodtryk
-
BayerAfsluttet
-
National Taiwan University Hospital Hsin-Chu BranchRekrutteringHypertension, essentiel | Hypertension, maskeretTaiwan
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldAfsluttetIdiopatisk pulmonal arteriel hypertension | Kronisk tromboembolisk pulmonal hypertensionDet Forenede Kongerige
-
University of Kansas Medical CenterRekrutteringPulmonal arteriel hypertension | Pulmonal hypertension | Kronisk tromboembolisk pulmonal hypertension | Pulmonal hypertension på grund af venstre hjertesygdom | Pulmonal hypertension, primær, 4 | Pulmonal hypertension, primær, 2 | Pulmonal hypertension, primær, 3 | Pulmonal hypertension, primær | Pulmonal...Forenede Stater
-
University of South FloridaTrukket tilbagePulmonal arteriel hypertension | Familiær primær pulmonal hypertension | Idiopatisk pulmonal arteriel hypertension | Primær pulmonal hypertensionForenede Stater
-
Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCAfsluttet
-
Centre Chirurgical Marie LannelongueUkendtKronisk trombo-embolisk pulmonal hypertension og pulmonal arteriel hypertensionFrankrig
-
Heidelberg UniversityMerck Sharp & Dohme LLCRekrutteringKronisk tromboembolisk pulmonal hypertension | Primær pulmonal arteriel hypertensionTyskland
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Aktiv, ikke rekrutterendeWhite Coat Hypertension | Hypertension, essentielForenede Stater
-
Vanderbilt University Medical CenterJohns Hopkins UniversityAfsluttetPulmonal arteriel hypertension | Idiopatisk pulmonal arteriel hypertension | Associeret pulmonal arteriel hypertension | Arvelig pulmonal arteriel hypertensionForenede Stater