Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity
NCT ID: NCT00998465
Last Updated: 2013-03-20
Study Results
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Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2009-11-30
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Obese, hypertension
Obese patients with hypertension and a body mass index 40-50 kg/m2
24-hour blood pressure
Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
Echocardiography
Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
Inert gas rebreathing
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)
Dexa-scan
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.
Plasma volume
The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
Glomerular filtration rate (GFR)
GFR and ECV are determined following injection of 3,7 MBq 51Cr-EDTA and postinjection samples three-four hours after injection.
Blood samples
p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
Urine analyses
24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
Diets with low and high sodium content
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.
Control
Control subjects without hypertension and body mass index \< 30 kg/m2
24-hour blood pressure
Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
Echocardiography
Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
Inert gas rebreathing
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)
Dexa-scan
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.
Plasma volume
The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
Glomerular filtration rate (GFR)
GFR and ECV are determined following injection of 3,7 MBq 51Cr-EDTA and postinjection samples three-four hours after injection.
Blood samples
p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
Urine analyses
24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
Diets with low and high sodium content
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.
Obese, normotension
Obese patients without hypertension and a BMI between 40-50 kg/m2
24-hour blood pressure
Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
Echocardiography
Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
Inert gas rebreathing
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)
Dexa-scan
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.
Plasma volume
The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
Glomerular filtration rate (GFR)
GFR and ECV are determined following injection of 3,7 MBq 51Cr-EDTA and postinjection samples three-four hours after injection.
Blood samples
p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
Urine analyses
24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
Diets with low and high sodium content
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.
Interventions
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24-hour blood pressure
Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
Echocardiography
Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
Inert gas rebreathing
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)
Dexa-scan
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.
Plasma volume
The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
Glomerular filtration rate (GFR)
GFR and ECV are determined following injection of 3,7 MBq 51Cr-EDTA and postinjection samples three-four hours after injection.
Blood samples
p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
Urine analyses
24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
Diets with low and high sodium content
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.
Eligibility Criteria
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Inclusion Criteria
* 12 participants with hypertension, defined as blood pressure \> 140/90 and/or use of antihypertensive medication and 12 participants without hypertension.
* Body mass index 40-50 kg/m2
* Caucasian.
* No hypertension or use of antihypertensive medication.
* Body mass index \< 30 kg/m2
Exclusion Criteria
* Chronic obstructive pulmonary disease
* Diabetes mellitus
* Medical treatment with sibutramine.
18 Years
70 Years
ALL
Yes
Sponsors
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Glostrup University Hospital, Copenhagen
OTHER
Zealand University Hospital
OTHER
Responsible Party
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University Hospital Koege
Principal Investigators
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Peter K Bonfils, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Koege
Morten Damgaard, MD, Ph.D.
Role: STUDY_DIRECTOR
Hvidovre Hospital, Copenhagen
Mustafa Taskiran, MD, Ph.D.
Role: STUDY_DIRECTOR
University Hospital Koege
Viggo B Kristiansen, MD
Role: STUDY_DIRECTOR
Glostrup Hospital, Copenhagen
Knud H Stokholm, MD
Role: STUDY_DIRECTOR
University Hospital Koege
Niels Gadsboll, MD, DMSc
Role: STUDY_CHAIR
University Hospital Koege
Locations
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University Hospital Koege, Department of Clinical Physiology and Nuclear Medicine
Koege, , Denmark
Countries
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References
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Bonfils PK, Taskiran M, Damgaard M, Goetze JP, Floyd AK, Funch-Jensen P, Kristiansen VB, Stockel M, Bouchelouche PN, Gadsboll N. Roux-en-Y gastric bypass alleviates hypertension and is associated with an increase in mid-regional pro-atrial natriuretic peptide in morbid obese patients. J Hypertens. 2015 Jun;33(6):1215-25. doi: 10.1097/HJH.0000000000000526.
Other Identifiers
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SJ-99
Identifier Type: -
Identifier Source: org_study_id
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