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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01494168
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:


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.

Condition or disease Intervention/treatment
Hypertension Obesity Procedure: Bariatric surgery (Roux-en-y bypass or sleeve gastrectomy)

Detailed Description:


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.


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.

Study Type : Observational
Actual Enrollment : 90 participants
Official Title: Longitudinal Assessment of the Effect of Bariatric Surgery on Arterial Function and Blood Pressure Target Organs Damage
Study Start Date : December 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Bariatric surgery (Roux-en-y bypass or sleeve gastrectomy)
    Bariatric surgery
    Other Names:
    • Roux-en-y bypass
    • sleeve gastrectomy

Primary Outcome Measures :
  1. Arterial stiffness [ Time Frame: 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)

Secondary Outcome Measures :
  1. Changes at 6 and 12 months [ Time Frame: 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
obese patient candidate for bariatric surgery

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01494168

University Hospital
Montpellier, France, 34925
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: Matthieu Sardinoux, M.D. UH Montpellier

Responsible Party: University Hospital, Montpellier Identifier: NCT01494168     History of Changes
Other Study ID Numbers: 8686
2010-A01447-32 ( Other Identifier: AFSSAPS )
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by University Hospital, Montpellier:
Arterial stiffness
Bariatric surgery

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases