Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity

This study has been completed.
Sponsor:
Collaborators:
University Hospital Koge
Glostrup University Hospital, Copenhagen
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00998465
First received: October 19, 2009
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Obesity
Hypertension
Other: 24-hour blood pressure
Other: Echocardiography
Other: Inert gas rebreathing
Radiation: Dexa-scan
Radiation: Plasma volume
Radiation: Glomerular filtration rate (GFR)
Other: Blood samples
Other: Urine analyses
Dietary Supplement: Diets with low and high sodium content

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity - Effect of Weight Loss Following Laparoscopic Gastric Bypass

Resource links provided by NLM:


Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • Sodium induced change in 24-hour blood pressure before and one year after laparoscopic gastric bypass. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Echocardiography: Dimensions, systolic and diastolic function before and one year after laparoscopic gastric bypass [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Non-invasive hemodynamic measurements (inert gas rebreathing) before and one year after laparoscopic gastric bypass [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Body composition: Dexa-scan, plasma volume and extracellular volume before and one year after laparoscopic gastric bypass [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Blood samples: MR-proANP, p-glucose, p-insulin [ Time Frame: One year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples: p-glucose, p-insulin, MR-proANP, hemoglobine, sodium, potassium, creatinine, albumine.

Urine collections: u-sodium, u-potassium, u-creatinine


Enrollment: 36
Study Start Date: November 2009
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obese, hypertension
Obese patients with hypertension and a body mass index 40-50 kg/m2
Other: 24-hour blood pressure
Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
Other: Echocardiography
Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
Other: 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)
Radiation: 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.
Radiation: Plasma volume
The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
Radiation: 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.
Other: Blood samples
p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
Other: Urine analyses
24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
Dietary Supplement: 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
Other: 24-hour blood pressure
Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
Other: Echocardiography
Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
Other: 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)
Radiation: 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.
Radiation: Plasma volume
The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
Radiation: 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.
Other: Blood samples
p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
Other: Urine analyses
24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
Dietary Supplement: 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
Other: 24-hour blood pressure
Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
Other: Echocardiography
Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
Other: 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)
Radiation: 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.
Radiation: Plasma volume
The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
Radiation: 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.
Other: Blood samples
p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
Other: Urine analyses
24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
Dietary Supplement: 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.

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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998465

Locations
Denmark
University Hospital Koege, Department of Clinical Physiology and Nuclear Medicine
Koege, Denmark, DK-4600
Sponsors and Collaborators
Roskilde County Hospital
University Hospital Koge
Glostrup University Hospital, Copenhagen
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
  More Information

No publications provided

Responsible Party: Peter Kramshoj Bonfils, MD, University Hospital Koege
ClinicalTrials.gov Identifier: NCT00998465     History of Changes
Other Study ID Numbers: SJ-99
Study First Received: October 19, 2009
Last Updated: March 19, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Roskilde County Hospital:
Obesity
Hypertension
Salt sensitivity
Laparoscopic gastric bypass
Bariatric surgery

Additional relevant MeSH terms:
Hypertension
Obesity
Obesity, Morbid
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014