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

NCT00998465 | Completed

• 1 other identifier: SJ-99
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; Hypertension; Salt sensitivity; Laparoscopic gastric bypass; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Sodium induced change in 24-hour blood pressure before and one year after laparoscopic gastric bypass.

  One year

Secondary Outcomes (4)

• Echocardiography: Dimensions, systolic and diastolic function before and one year after laparoscopic gastric bypass

  One year

• Non-invasive hemodynamic measurements (inert gas rebreathing) before and one year after laparoscopic gastric bypass

  One year

• Body composition: Dexa-scan, plasma volume and extracellular volume before and one year after laparoscopic gastric bypass

  One year

• Blood samples: MR-proANP, p-glucose, p-insulin

  One year

Study Arms (3)

Obese, hypertension

Obese patients with hypertension and a body mass index 40-50 kg/m2

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

Control

Control subjects without hypertension and body mass index \< 30 kg/m2

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

Obese, normotension

Obese patients without hypertension and a BMI between 40-50 kg/m2

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

Interventions

24-hour blood pressure OTHER

Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night

Control; Obese, hypertension; Obese, normotension

Echocardiography OTHER

Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.

Control; Obese, hypertension; Obese, normotension

Inert gas rebreathing OTHER

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)

Control; Obese, hypertension; Obese, normotension

Dexa-scan RADIATION

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.

Control; Obese, hypertension; Obese, normotension

Plasma volume RADIATION

The test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation.

Control; Obese, hypertension; Obese, normotension

Glomerular filtration rate (GFR) RADIATION

GFR and ECV are determined following injection of 3,7 MBq 51Cr-EDTA and postinjection samples three-four hours after injection.

Control; Obese, hypertension; Obese, normotension

Blood samples OTHER

p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine

Control; Obese, hypertension; Obese, normotension

Urine analyses OTHER

24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.

Control; Obese, hypertension; Obese, normotension

Diets with low and high sodium content DIETARY_SUPPLEMENT

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; Obese, hypertension; Obese, normotension

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Caucasians fulfilling the criteria for laparoscopic gastric bypass.
• 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

You may not qualify if:

• Pregnancy
• Chronic obstructive pulmonary disease
• Diabetes mellitus
• Medical treatment with sibutramine.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (1)

University Hospital Koege, Department of Clinical Physiology and Nuclear Medicine

Koege, DK-4600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 25668345 DERIVED

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

MeSH Terms

Conditions

Obesity; Hypertension

Interventions

Blood Pressure; Absorptiometry, Photon; Plasma Volume; Glomerular Filtration Rate; Blood Specimen Collection; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Blood Volume; Blood Physiological Phenomena; Kidney Function Tests; Diagnostic Techniques, Urological; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Peter K Bonfils, MD

  University Hospital Koege

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

• Niels Gadsboll, MD, DMSc

  University Hospital Koege

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 20, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

DK (1)