ObesityNCT00998465
Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity
An observational study of Obesity and Hypertension, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- 24-hour blood pressure, Echocardiography and Inert gas rebreathing
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
- Caucasian.
- No hypertension or use of antihypertensive medication.
- Body mass index < 30 kg/m2
Who cannot join
- Pregnancy
- Chronic obstructive pulmonary disease
- Diabetes mellitus
- Medical treatment with sibutramine.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital Koege, Department of Clinical Physiology and Nuclear Medicine
Koege, DK-4600
About this study
Official title: Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity - Effect of Weight Loss Following Laparoscopic Gastric Bypass
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.
Read the 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.
- Conditions
- Obesity, Hypertension
- Being tested
- 24-hour blood pressure, Echocardiography, Inert gas rebreathing, Dexa-scan, Plasma volume
- Keywords
- Obesity, Hypertension, Salt sensitivity, Laparoscopic gastric bypass, Bariatric surgery
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour blood pressureOther
Blood pressure is measured every 15 minutes in the daytime and every 30 minutes at night
EchocardiographyOther
Standard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function.
Inert gas rebreathingOther
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-scanRadiation
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 volumeRadiation
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)Radiation
GFR and ECV are determined following injection of 3,7 MBq 51Cr-EDTA and postinjection samples three-four hours after injection.
Blood samplesOther
p-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine
Urine analysesOther
24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine.
Diets with low and high sodium contentDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Obese, hypertension | Obese patients with hypertension and a body mass index 40-50 kg/m2 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium induced change in 24-hour blood pressure before and one year after laparoscopic gastric bypass.
Measured: One year
Secondary outcomes (4)
Echocardiography: Dimensions, systolic and diastolic function before and one year after laparoscopic gastric bypass
Measured: One year
Non-invasive hemodynamic measurements (inert gas rebreathing) before and one year after laparoscopic gastric bypass
Measured: One year
Body composition: Dexa-scan, plasma volume and extracellular volume before and one year after laparoscopic gastric bypass
Measured: One year
Blood samples: MR-proANP, p-glucose, p-insulin
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Investigators
- Peter K Bonfils, MD, Principal investigator, University Hospital KoegeMorten Damgaard, MD, Ph.D., Study director, Hvidovre Hospital, CopenhagenMustafa Taskiran, MD, Ph.D., Study director, University Hospital KoegeViggo B Kristiansen, MD, Study director, Glostrup Hospital, CopenhagenKnud H Stokholm, MD, Study director, University Hospital KoegeNiels Gadsboll, MD, DMSc, Study chair, University Hospital Koege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998465
- Sponsor's protocol ID
- SJ-99
- Status last verified
- Mar 2013
- First submitted
- 19 Oct 2009
- Last updated
- 20 Mar 2013
- Results posted
- No
Publications
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.
PubMed 25668345
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamics, Salt Sensitivity and Body Composition in Patients With Morbid Obesity - Effect of Weight Loss Following Laparoscopic Gastric Bypass
- ClinicalTrials.gov ID
- NCT00998465
- Acronym / sponsor ID
- SJ-99
- Conditions
- Obesity, Hypertension
- Keywords
- Obesity, Hypertension, Salt sensitivity, Laparoscopic gastric bypass, Bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese, 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 contentObese patients with hypertension and a body mass index 40-50 kg/m2 |
| Control | – | 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 contentControl subjects without hypertension and body mass index < 30 kg/m2 |
| Obese, normotension | – | 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 contentObese patients without hypertension and a BMI between 40-50 kg/m2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
- Caucasian.
- No hypertension or use of antihypertensive medication.
Key exclusion criteria (4 listed)
- Pregnancy
- Chronic obstructive pulmonary disease
- Diabetes mellitus
- Medical treatment with sibutramine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hour blood pressureBlood pressure is measured every 15 minutes in the daytime and every 30 minutes at night | Other | Control, Obese, hypertension, Obese, normotension |
| EchocardiographyStandard 2-D and m-mode echocardiography with determination of dimensions, systolic, and diastolic function. | Other | Control, Obese, hypertension, Obese, normotension |
| Inert gas rebreathingCardiac output, stroke volume and total peripheral resistance are tested at rest and during exercise (bicycle ergometer) using non-invasive equipment (inert gas rebreathing - Innocor) | Other | Control, Obese, hypertension, Obese, normotension |
| Dexa-scanFat 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 | Control, Obese, hypertension, Obese, normotension |
| Plasma volumeThe test is performed using 5 MBq technetium-labeled albumine (99mTc-albumine - Vasculosis) with several postinjection samples for accurate zero-time extrapolation. | Radiation | Control, Obese, hypertension, Obese, normotension |
| 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. | Radiation | Control, Obese, hypertension, Obese, normotension |
| Blood samplesp-glucose, p-insulin, NT-proBNP, hemoglobin, potassium, sodium, creatinine, albumine | Other | Control, Obese, hypertension, Obese, normotension |
| Urine analyses24-hour urine collections with determination of u-sodium, u-potassium and u-creatinine. | Other | Control, Obese, hypertension, Obese, normotension |
| Diets with low and high sodium contentParticipants 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. | Dietary supplement | Control, Obese, hypertension, Obese, normotension |
Primary outcome
Sodium induced change in 24-hour blood pressure before and one year after laparoscopic gastric bypass.
Time frame: One year
4 secondary outcomes
Echocardiography: Dimensions, systolic and diastolic function before and one year after laparoscopic gastric bypass
Time frame: One year
Non-invasive hemodynamic measurements (inert gas rebreathing) before and one year after laparoscopic gastric bypass
Time frame: One year
Body composition: Dexa-scan, plasma volume and extracellular volume before and one year after laparoscopic gastric bypass
Time frame: One year
Blood samples: MR-proANP, p-glucose, p-insulin
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- Derived from this study: PubMed 25668345Bonfils 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter K Bonfils, MD principal investigator
University Hospital Koege
Morten Damgaard, MD, Ph.D. study director
Hvidovre Hospital, Copenhagen
Mustafa Taskiran, MD, Ph.D. study director
University Hospital Koege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Hypertension, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sodium induced change in 24-hour blood pressure before and one year after laparoscopic gastric bypass. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00998465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.