University Hospital Koege, Department of Clinical Physiology and Nuclear Medicine
Koege, DK-4600, Denmark
NCT Number: NCT00998465
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.
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Notify Me18 year–70 year
All sexes
Observational
Koege, DK-4600, Denmark
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(cases):
Inclusion criteria
(controls):
Exclusion criteria
(all):
Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
Cardiac output, stroke volume and total peripheral resistance are tested at rest and during exercise (bicycle ergometer) using non-invasive equipment (inert gas rebreathing - Innocor)
Fat mass and fat free mass is determined with a whole body Dexa scan, and bone mineral density is tested with Dexa-scans of the lumbar spine and proximal femur.
The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
GFR and ECV are determined following injection of 3,7 MBq 51Cr-EDTA and postinjection samples three-four hours after injection.
p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
Participants are subjected to 5 days of low (90 mmol/day) and high (250 mmol/day) sodium intake in a randomized order before and 1 year after laparoscopic gastric bypass surgery.
Time frame: One year
Time frame: One year
Time frame: One year
Time frame: One year
Time frame: One year
Zealand University Hospital
Other
Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity - Effect of Weight Loss Following Laparoscopic Gastric Bypass
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