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Clinical Trials/NCT00998465
NCT00998465CompletedNot Applicable

Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity - Effect of Weight Loss Following Laparoscopic Gastric Bypass

Zealand University Hospital1 site in 1 country36 target enrollmentStarted: November 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Sodium induced change in 24-hour blood pressure before and one year after laparoscopic gastric bypass.

Study Overview

Brief Summary

The purpose of this study is to evaluate the effect of high vs. low sodium intake on blood pressure and system hemodynamics in patients with morbid obesity and to evaluate the impact of laparoscopic gastric bypass on blood pressure, salt sensitivity and body composition in morbidly obese patients. Furthermore, we wants to describe the hemodynamic mechanisms involved in the amelioration of blood pressure during long-term weight loss.

Detailed Description

Overweight and obesity are rapidly increasing in Western countries and are associated with increased mortality and morbidity. The increased morbidity is assumed to be mediated mainly by insulin resistance, diabetes, hypertension and lipid disturbances, but obesity also represents an independent risk factor for cardiovascular disease.

Obesity is associated with an increased risk of hypertension but the pathophysiological basis is not fully established. Several studies have indicated that blood pressure of obese patients could be more dependent on dietary sodium intake than the blood pressure of non-obese patients(as it is the case for patients with essential hypertension)and that this sodium sensitivity of blood pressure is lost after weight loss.

To date, bariatric surgery is the only therapy resulting in substantial and durable long-term weight loss, and the beneficial effects on obesity-related co-morbidities have been well documented. Laparoscopic gastric bypass results in a remarkable improvement of glucose homeostasis and a resolution of diabetes, that typically occurs too fast to be accounted for by weight loss alone. Furthermore, an immediate reduction of blood pressure following laparoscopic gastric bypass has been demonstrated in morbidly obese patients with hypertension as early as one week after the operation. As with the rapid reduction of diabetes, the antihypertensive effect of the procedure might be a consequence of the rearrangement of the gastrointestinal anatomy.

With this study, we want to evaluate the effect of high vs. low sodium intake on blood pressure and system hemodynamics in patients with morbid obesity and to evaluate the impact of laparoscopic gastric bypass on blood pressure, salt sensitivity and body composition in morbidly obese patients. Furthermore, we wants to describe the hemodynamic mechanisms involved in the amelioration of blood pressure during long-term weight loss. Therefore, patients are examined before, 4-6 weeks after and one year after laparoscopic gastric bypass.

Before and one year after the operation, the patients are examined two times; in a five days period of a low dietary sodium consumption and in a five days period of a high sodium consumption respectively. Four-six weeks following the operation, the patients are examined once on their usual diet.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Sodium induced change in 24-hour blood pressure before and one year after laparoscopic gastric bypass.

Time Frame: One year

Secondary Outcomes

  • Non-invasive hemodynamic measurements (inert gas rebreathing) before and one year after laparoscopic gastric bypass(One year)
  • Echocardiography: Dimensions, systolic and diastolic function before and one year after laparoscopic gastric bypass(One year)
  • Body composition: Dexa-scan, plasma volume and extracellular volume before and one year after laparoscopic gastric bypass(One year)
  • Blood samples: MR-proANP, p-glucose, p-insulin(One year)

Investigators

Sponsor Class
Other

Study Sites (1)

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