Abdominal ObesityNCT02068781
Aldosterone, Microvascular Function and Salt-sensitivity
A study testing Low-sodium diet and High-sodium diet in people with Abdominal Obesity and Metabolic Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Currently, the incidence of obesity and obesity-related disorders is reaching epidemic proportions, which entails an increasing burden for health care systems. The association of obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such as insulin resistance and hypertension, is… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity, Metabolic Syndrome, Sodium-sensitivity
- What is being tested?
- Low-sodium diet and High-sodium diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to Oct 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese individuals
- Age 18-65 years
- Caucasian
- Waist circumference > 102 cm (men)/> 88 cm (women)
- Lean individuals
- Age 18-65 years
- Caucasian
- Waist circumference < 94 cm (men)/< 80 cm (women)
Who cannot join
- Obese/lean individuals
- Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
- Diabetes mellitus/impaired glucose metabolism (fasting glucose values > 5.6 mmol/L
- Stage 3 hypertension (blood pressure > 180/110 mm Hg)
- Unstable or severe pulmonary disease
- Unstable or severe thyroid disorders
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- Inflammatory diseases
- Smoking
- Alcohol use > 2 U/day (women)/> 3 U/day (men)
- Use of antihypertensive, lipid-lowering or glucose-lowering medications
- Use of corticosteroids and regular use of NSAIDs
- eGFR< 60 mL/min
- Impairment of hepatic function
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aldosterone-induced Microvascular Dysfunction as a Cause of Salt-sensitivity in Obesity?
Currently, the incidence of obesity and obesity-related disorders is reaching epidemic proportions, which entails an increasing burden for health care systems. The association of obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such as insulin resistance and hypertension, is often referred to as the metabolic syndrome. During recent years, salt-sensitivity of blood pressure has emerged as an additional cardiovascular risk factor that is related to obesity and other key components of the metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a link between insulin resistance and hypertension in obese individuals. In addition, impairment of microvascular function was found to be associated with salt-sensitivity of blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance. Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but was also found to impair endothelial function and thus lower NO-availability, which is characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are associated with both hypertension and insulin resistance, which is illustrated in patients with primary aldosteronism, but also in the general population.
The investigators hypothesize that increased aldosterone levels in obese individuals lead to impairment of microvascular function through reduction of NO-availability. This microvascular dysfunction is suggested to play a central role in the pathogenesis of salt-sensitive hypertension and insulin resistance.
- Conditions
- Abdominal Obesity, Metabolic Syndrome, Sodium-sensitivity, Insulin Resistance, Hypertension
- Being tested
- Low-sodium diet, High-sodium diet
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome, Insulin Resistance, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-sodium dietDietary supplement
50 mmol NaCl per 24h
High-sodium dietDietary supplement
250 mmol NaCl per 24h
| Study group | Role | What they receive |
|---|---|---|
| Start with low-sodium diet | Active comparator | One week of low-sodium diet, followed by a two-week wash-out period and subsequently, another week of high-sodium diet Receives: Dietary Supplement: Low-sodium diet; Dietary Supplement: High-sodium diet |
| Start with high-sodium diet | Active comparator | One week of high-sodium diet, followed by a two-week wash-out period and subsequently, another week of low-sodium diet Receives: Dietary Supplement: Low-sodium diet; Dietary Supplement: High-sodium diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in capillary recruitment between low- and high sodium diets
Measured: One week low-sodium diet; wash-out period of two weeks; one week high-sodium diet; order of respective diets is randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Schütten, Maastricht University Medical Center
- Investigators
- C.D.A. Stehouwer, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068781
- Sponsor's protocol ID
- 47438/IMP10124
- Status last verified
- May 2017
- First submitted
- 19 Feb 2014
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhou TL, Schutten MTJ, Kroon AA, Henry RMA, Houben AJHM, van der Kallen CJH, van Greevenbroek MMJ, de Leeuw PW, Stehouwer CDA. Urinary Sodium Excretion and Salt Intake Are Not Associated With Blood Pressure Variability in a White General Population. J Am Heart Assoc. 2023 Jan 3;12(1):e026578. doi: 10.1161/JAHA.122.026578. Epub 2022 Dec 24.
PubMed 36565181Schutten MT, Kusters YH, Houben AJ, Niessen HE, Op 't Roodt J, Scheijen JL, van de Waardenburg MP, Schalkwijk CG, de Leeuw PW, Stehouwer CD. Glucocorticoids affect metabolic but not muscle microvascular insulin sensitivity following high versus low salt intake. JCI Insight. 2020 Mar 26;5(6):e127530. doi: 10.1172/jci.insight.127530.
PubMed 32107343
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aldosterone-induced Microvascular Dysfunction as a Cause of Salt-sensitivity in Obesity?
- ClinicalTrials.gov ID
- NCT02068781
- Acronym / sponsor ID
- 47438/IMP10124
- Conditions
- Abdominal Obesity, Metabolic Syndrome, Sodium-sensitivity, Insulin Resistance, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 Feb 2014 (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.
Currently, the incidence of obesity and obesity-related disorders is reaching epidemic proportions, which entails an increasing burden for health care systems. The association of obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such as insulin resistance and hypertension, is often referred to as the metabolic syndrome. During recent years, salt-sensitivity of blood pressure has emerged as an additional cardiovascular risk factor that is related to obesity and other key components of the metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a link between insulin resistance and hypertension in obese individuals. In addition, impairment of microvascular function was found to be associated with salt-sensitivity of blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance. Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but was also found to impair endothelial function and thus lower NO-availability, which is characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are associated with both hypertension and insulin resistance, which is illustrated in patients with primary aldosteronism, but also in the general population.
The investigators hypothesize that increased aldosterone levels in obese individuals lead to impairment of microvascular function through reduction of NO-availability. This microvascular dysfunction is suggested to play a central role in the pathogenesis of salt-sensitive hypertension and insulin resistance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Start with low-sodium diet | Active comparator | Dietary Supplement: Low-sodium diet, Dietary Supplement: High-sodium dietOne week of low-sodium diet, followed by a two-week wash-out period and subsequently, another week of high-sodium diet |
| Start with high-sodium diet | Active comparator | Dietary Supplement: Low-sodium diet, Dietary Supplement: High-sodium dietOne week of high-sodium diet, followed by a two-week wash-out period and subsequently, another week of low-sodium diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Obese individuals
- Age 18-65 years
- Caucasian
- Waist circumference > 102 cm (men)/> 88 cm (women)
- Lean individuals
Key exclusion criteria (14 listed)
- Obese/lean individuals
- Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
- Diabetes mellitus/impaired glucose metabolism (fasting glucose values > 5.6 mmol/L
- Stage 3 hypertension (blood pressure > 180/110 mm Hg)
- Unstable or severe pulmonary disease
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 |
|---|---|---|
| Low-sodium diet50 mmol NaCl per 24h | Dietary supplement | Start with high-sodium diet, Start with low-sodium diet |
| High-sodium diet250 mmol NaCl per 24h | Dietary supplement | Start with high-sodium diet, Start with low-sodium diet |
Primary outcome
Difference in capillary recruitment between low- and high sodium diets
Time frame: One week low-sodium diet; wash-out period of two weeks; one week high-sodium diet; order of respective diets is randomized
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 19 May 2017.
- Derived from this study: PubMed 36565181Zhou TL, Schutten MTJ, Kroon AA, Henry RMA, Houben AJHM, van der Kallen CJH, van Greevenbroek MMJ, de Leeuw PW, Stehouwer CDA. Urinary Sodium Excretion and Salt Intake Are Not Associated With Blood Pressure Variability in a White General Population. J Am Heart Assoc. 2023 Jan 3;12(1):e026578. doi: 10.1161/JAHA.122.026578. Epub 2022 Dec 24.
- Derived from this study: PubMed 32107343Schutten MT, Kusters YH, Houben AJ, Niessen HE, Op 't Roodt J, Scheijen JL, van de Waardenburg MP, Schalkwijk CG, de Leeuw PW, Stehouwer CD. Glucocorticoids affect metabolic but not muscle microvascular insulin sensitivity following high versus low salt intake. JCI Insight. 2020 Mar 26;5(6):e127530. doi: 10.1172/jci.insight.127530.
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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.
C.D.A. Stehouwer, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-sodium diet and High-sodium diet in people with Abdominal Obesity and Metabolic Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
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 8 inclusion and 14 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 19 May 2017. 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 Netherlands. 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?
Difference in capillary recruitment between low- and high sodium diets (time frame: One week low-sodium diet; wash-out period of two weeks; one week high-sodium diet; order of respective diets is randomized). 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 NCT02068781, which also lists 2 linked publications.
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 19 May 2017.