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

Summary

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.

Conditions

• Obesity
• Hypertension

Interventions

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.

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen

  collaborator OTHER

• Zealand University Hospital

  lead OTHER

Principal Investigators

• Peter K Bonfils, MD · University Hospital Koege

• Morten Damgaard, MD, Ph.D. · Hvidovre Hospital, Copenhagen

• Mustafa Taskiran, MD, Ph.D. · University Hospital Koege

• Viggo B Kristiansen, MD · Glostrup Hospital, Copenhagen

• Knud H Stokholm, MD · University Hospital Koege

• Niels Gadsboll, MD, DMSc · University Hospital Koege

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2012-12-31

Completion

2013-01-31

Countries

• Denmark