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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01494168
First received: November 17, 2011
Last updated: December 15, 2011
Last verified: December 2011
  Purpose

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.


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

Study Type: Observational
Official Title: Longitudinal Assessment of the Effect of Bariatric Surgery on Arterial Function and Blood Pressure Target Organs Damage

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Arterial stiffness [ Time Frame: 6 and 12 month (plus or minus 30 days) after bariatric surgery ] [ Designated as safety issue: No ]
    Change in Arterial stiffness at 6 and 12 months(determined non-invasively by measurement of PWV, central pressure and reflection wavelength)


Secondary Outcome Measures:
  • Changes at 6 and 12 months [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 90
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Bariatric surgery (Roux-en-y bypass or sleeve gastrectomy)
    Bariatric surgery
    Other Names:
    • Roux-en-y bypass
    • sleeve gastrectomy
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

obese patient candidate for bariatric surgery

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494168

Locations
France
University Hospital Recruiting
Montpellier, France, 34925
Contact: Matthieu Sardinoux, M.D.    +334 67 33 84 08    m-sardinoux@chu-montpellier.fr   
Principal Investigator: Matthieu Sardinoux, M.D.         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Matthieu Sardinoux, M.D. UH Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01494168     History of Changes
Other Study ID Numbers: UF 8686, 2010-A01447-32
Study First Received: November 17, 2011
Last Updated: December 15, 2011
Health Authority: France: Committee for the Protection of Personnes

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

Additional relevant MeSH terms:
Hypertension
Obesity
Body Weight
Cardiovascular Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014