Obesity Clinical Trial
Official title:
Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity - Effect of Weight Loss Following Laparoscopic Gastric Bypass
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.
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.
The protocol comprise three sub studies:
1. The effect of high vs low sodium intake on blood pressure and hemodynamics in the
morbid obese patient - preoperative study.
2. Effect of gastric bypass surgery on blood pressure, hemodynamics and salt-sensitivity -
1 year follow-up.
3. Effect of gastric bypass surgery on echocardiographic parameters - 1 year follow-up.
;
Observational Model: Case Control, Time Perspective: Cross-Sectional
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