- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00998465
Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity
Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity - Effect of Weight Loss Following Laparoscopic Gastric Bypass
Study Overview
Status
Conditions
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.
The protocol comprise three sub studies:
- The effect of high vs low sodium intake on blood pressure and hemodynamics in the morbid obese patient - preoperative study.
- Effect of gastric bypass surgery on blood pressure, hemodynamics and salt-sensitivity - 1 year follow-up.
- Effect of gastric bypass surgery on echocardiographic parameters - 1 year follow-up.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Koege, Denmark, DK-4600
- University Hospital Koege, Department of Clinical Physiology and Nuclear Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The cases are recruited from the Bariatric Clinics at Glostrup Hospital, Koege Hospital and The Private Hospital Hamlet.
Controls are recruited through public advertisement
Description
Inclusion Criteria (cases):
- Caucasians fulfilling the criteria for laparoscopic gastric bypass.
- 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
Inclusion Criteria (controls):
- Caucasian.
- No hypertension or use of antihypertensive medication.
- Body mass index < 30 kg/m2
Exclusion Criteria (all):
- Pregnancy
- Chronic obstructive pulmonary disease
- Diabetes mellitus
- Medical treatment with sibutramine.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obese, hypertension
Obese patients with hypertension and a body mass index 40-50 kg/m2
|
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.
|
Control
Control subjects without hypertension and body mass index < 30 kg/m2
|
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.
|
Obese, normotension
Obese patients without hypertension and a BMI between 40-50 kg/m2
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sodium induced change in 24-hour blood pressure before and one year after laparoscopic gastric bypass.
Time Frame: One year
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One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Echocardiography: Dimensions, systolic and diastolic function before and one year after laparoscopic gastric bypass
Time Frame: One year
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One year
|
Non-invasive hemodynamic measurements (inert gas rebreathing) before and one year after laparoscopic gastric bypass
Time Frame: One year
|
One year
|
Body composition: Dexa-scan, plasma volume and extracellular volume before and one year after laparoscopic gastric bypass
Time Frame: One year
|
One year
|
Blood samples: MR-proANP, p-glucose, p-insulin
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter K Bonfils, MD, University Hospital Koege
- Study Director: Morten Damgaard, MD, Ph.D., Hvidovre Hospital, Copenhagen
- Study Director: Mustafa Taskiran, MD, Ph.D., University Hospital Koege
- Study Director: Viggo B Kristiansen, MD, Glostrup Hospital, Copenhagen
- Study Director: Knud H Stokholm, MD, University Hospital Koege
- Study Chair: Niels Gadsboll, MD, DMSc, University Hospital Koege
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJ-99
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