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Bariatric Surgery, Arterial Stiffness and Target Organ Damage Study (BASTOD) (BASTOD)

30. november 2016 opdateret af: University Hospital, Montpellier

Longitudinal Assessment of the Effect of Bariatric Surgery on Arterial Function and Blood Pressure Target Organs Damage

Introduction:

Obesity is a major public health problem, associated with many morbidities, including metabolic and cardiovascular disease (CVD). High blood pressure (hypertension) is the most common comorbidity and one of the major risk factors for CVD and kidney failure. It has been described an almost linear relationship between body mass index (BMI) and the level of blood pressure (BP), but the mechanisms underlying this relationship are complex and incompletely understood : activation of renin-angiotensin-aldosterone and sympathetic nervous systems, alterations in systemic hemodynamics and arterial parameters; a significant correlation between overall and / or visceral obesity and arterial stiffness assessed by carotid-femoral pulse wave velocity (PWV) has been observed.

By its effectiveness in terms of magnitude and sustainability of weight loss, bariatric surgery is becoming increasingly important in the management of obesity and the prevention of its comorbidities. It reduces all-cause as well as CV mortality. Bariatric surgery allows a resolution of the metabolic syndrome (in 2 out of 3 patients) and diabetes (in 5 out of 6 patients), but its effect on blood pressure remains inconstant and transient. The reasons for this limitation and the detailed effects of bariatric surgery on hemodynamics and arterial parameters have been poorly studied. Of note, a reduction in left ventricular hypertrophy, an improvement in diastolic dysfunction and aortic distensibility assessed by ultrasound or MRI have been observed.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Objective:

The study aims to (a) estimate the effects of bariatric surgery on the function of large arteries (determined non-invasively by measurement of PWV, pressure central reflection wavelength) in a population of obese grade 2 or 3, and (b) evaluate the respective role of weight loss, the change in metabolic parameters, and the decline in BP on changes in the function of large arteries and on markers of target organ alterations after surgery.

Methods:

This is a prospective longitudinal study with assessment of arterial stiffness before and after 6 and 12 months following bariatric surgery. Ninety grade 2-3 obese patients with an indication of bariatric surgery will be included. Arterial stiffness is estimated by the aortic PWV (SphygmoCor®) at baseline and after 6 and 12 months following surgery. Changes in the central pressure, wave reflection, the PA device, and markers of target organ alteration (left ventricular mass, LVM, glomerular filtration rate, GFR, urinary albumin excretion, EUA; caliber of retinal vessels as assessed by retinography) will be the secondary objectives.

To study the evolution of PWV in connection with weight loss, a linear mixed model is used based on data collected for each patient every time. Correlations between different parameters will be studied each time. Changes in secondary endpoints over time will be correlated to changes in weight, BMI, percentage loss of excess weight and blood pressure.

Expected results and their prospects:

Weight loss surgery should lead to a rapid and sustained weight loss, improved arterial function parameters (BP, arterial stiffness) and markers of target organ damage (GFR, UAE, LVM, caliber of retinal vessels).

The analysis of the relation between the metabolic / hemodynamic responses and target organ damage should enable us to identify consistent pathophysiological mechanisms, and refine our understanding of the consequences of bariatric surgery.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

90

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Montpellier, Frankrig, 34925
        • University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

obese patient candidate for bariatric surgery

Beskrivelse

Inclusion criteria:

  • BMI > 40 kg/m2 or BMI 35-40 with major comorbidities
  • Age between 18-60 years
  • Obesity evolving for more than 5 years
  • Failure of medical treatment
  • Elimination of hormonal causes

Exclusion criteria:

  • Uncontrolled hypertension (SBP > 160 mmHg and DBP> 100 mmHg).
  • History of cardiovascular disease or signs of clinical atheroma: stroke, myocardial infarction and coronary heart disease (angina), peripheral arterial disease (no pulse, claudication), aortic aneurysm (anterior abdominal palpation or imaging ), carotid bruit
  • Plasma creatinine > 130 micromol/L and/or proteinuria > 300 mg/24 h and/or dipstick hematuria.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Arterial stiffness
Tidsramme: 6 and 12 month (plus or minus 30 days) after bariatric surgery
Change in Arterial stiffness at 6 and 12 months(determined non-invasively by measurement of PWV, central pressure and reflection wavelength)
6 and 12 month (plus or minus 30 days) after bariatric surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes at 6 and 12 months
Tidsramme: at 6 and 12 months
Changes at 6 and 12 months in central pressure, wave reflection, blood pressure , and target organ damage (left ventricular mass, glomerular filtration rate, urinary albumin excretion, caliber of retinal vessels)
at 6 and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Montpellier

Efterforskere

  • Ledende efterforsker: Matthieu Sardinoux, M.D., UH Montpellier

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2011

Primær færdiggørelse (Faktiske)

1. januar 2015

Studieafslutning (Faktiske)

1. marts 2016

Datoer for studieregistrering

Først indsendt

17. november 2011

Først indsendt, der opfyldte QC-kriterier

15. december 2011

Først opslået (Skøn)

16. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 8686
  • 2010-A01447-32 (Anden identifikator: AFSSAPS)

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 .

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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