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

NCT01494168 | Completed DMC

• 2 other identifiers: 86862010-A01447-32
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Obesity

Keywords

Hypertension; Arterial stiffness; Obesity; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Arterial stiffness

  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

Secondary Outcomes (1)

• Changes at 6 and 12 months

  at 6 and 12 months

Interventions

Bariatric surgery (Roux-en-y bypass or sleeve gastrectomy) PROCEDURE

Bariatric surgery

Also known as: Roux-en-y bypass, sleeve gastrectomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

obese patient candidate for bariatric surgery

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital

Montpellier, 34925, France

Location

MeSH Terms

Conditions

Hypertension; Obesity

Interventions

Bariatric Surgery; Anastomosis, Roux-en-Y

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Anastomosis, Surgical; Digestive System Surgical Procedures

Study Officials

• Matthieu Sardinoux, M.D.

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: December 16, 2011
• Study Start: December 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

FR (1)