- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01692327
Study About High Fat Meal and Postprandial Lipemia
Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women
The hypothesis of the proposed project is that after a fat overload, the postprandial response is different in both groups, suggesting that the LPP will present the most significant damage in endothelial vasomotion in obese individuals, especially those with GI and T2DM. After the fat overload, we hypothesized that there will be a worsening of endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but also find lower concentrations of incretins in OB/DM2 group compared to other groups.
These hypotheses may be confirmed by techniques for evaluating microvascular function, the use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic and cardiovascular read by Multiplex kit.
Studieoversigt
Detaljeret beskrivelse
Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2) treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.
Microcirculation parameters and blood tests will be assessed at baseline and after this, the women will receive a high-fat meal containing croissant, salami, whole milk and cheddar cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as well as blood collection.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Rio de janeiro, Brasilien, 20550900
- Rio de Janeiro State University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- all patients should have obesity class I (BMI between 30 and 35kg/m2);
- Submit diabetes mellitus without further treatment or be obese non-diabetic or glucose intolerant;
- Presenting the age between 19 to 40 years.
- Waist circumference> 80 cm (IDF)
Exclusion Criteria:
- Renal disease, coronary or peripheral vascular, hematologic or hepatic impairment;
- Presence of dyslipidemia;
- smokers;
- Significant loss of body weight six months prior to the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Obese Group
Obese group with fat overload intake.
|
|
|
Andet: Control Group
Control Group + fat overload intake
|
|
|
Andet: Glucose Intolerance
glucose intolerance + fat overload intake
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Microvascular function
Tidsramme: up to 180 minutes after high fat meal
|
up to 180 minutes after high fat meal
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
incretins hormones
Tidsramme: basal, 30, 60, 120,180 minutes after high fat meal
|
We will assess incretins hormones by multiplex
|
basal, 30, 60, 120,180 minutes after high fat meal
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
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
Andre undersøgelses-id-numre
- Biovasc-02
- Biovasc002 (Registry Identifier: Over load project)
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 Fedtrigt måltid
-
University Psychiatric Clinics BaselIkke rekrutterer endnuDepressiv lidelse | Større depressiv lidelse | Depression, Bipolar
-
NYU Langone HealthNational Institute on Deafness and Other Communication Disorders (NIDCD)Rekruttering
-
University of PittsburghArmed Forces Institute of Regenerative MedicineRekrutteringAnsigtsfejlForenede Stater
-
Erzurum Technical UniversityAfsluttetFastende stat | Kognitive evnerTyrkiet (Türkiye)
-
Zhujiang HospitalThe First Affiliated Hospital of Anhui Medical University; Xiangya Hospital... og andre samarbejdspartnereAfsluttetKnæ slidgigt | Artropati af knæKina
-
Green Chef CorporationCitruslabsAfsluttetSund diæt | Sund ernæringForenede Stater
-
Midwest Heart & Vascular SpecialistsRekrutteringAL Amyloidose | Amyloid | Hjerte amyloidose | Amyloidose Hjerte | Systemisk amyloidose | ATTR Amyloidose vildtype | Infiltrativ kardiomyopati, amyloidForenede Stater
-
Riphah International UniversityRekrutteringMuskelstramhedPakistan
-
Barron Associates, Inc.University of VirginiaAfsluttetVirtual reality | ErgoterapiForenede Stater
-
University of VermontRekruttering