Metabolic SyndromePhase 4NCT02034435
Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism
A Phase 4 study testing Low Sodium diet plus Salt tablet, Epleronone and Amlodipine in people with Metabolic Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs glycemic control via effects on insulin sensitivity and insulin secretion. Aim 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Low Sodium diet plus Salt tablet, Epleronone and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory subjects, 18 to 70 years of age, inclusive
- For female subjects, the following conditions must be met:
- postmenopausal status for at least 1 year, or
- status-post surgical sterilization, or
- if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day.
- Metabolic Syndrome as defined by the presence of > 3 of the following:
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- Systolic Blood Pressure > 130 mm Hg OR Diastolic Blood Pressure > 85 mm Hg.
- Glucose Intolerance (Fasting Plasma Glucose ≥ 100 mg/dL)
- Increased triglyceride level > 150mg/dL (1.7mmol/L)
- Decreased levels of HDL cholesterol (For males, less than 40 mg/dL; For females, less than 50 mg/dL)
- Waist circumference (For males, greater than 40 inches; For females, greater than 35 inches)
Who cannot join
- type 1 Diabetes
- Type II Diabetes
- Impaired renal function
- Prior allergies to medications used in the study protocol
- Screening plasma potassium >5.5 mmol/L or sodium <135 mmol/L
- Cardiovascular disease
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- Use of hormone replacement therapy
- Breast-feeding
- Treatment with anticoagulants
- History of serious neurologic disease
- History or presence of immunological or hematological disorders
- Diagnosis of asthma requiring use of inhaled beta agonist
- Clinically significant gastrointestinal impairment
- Impaired hepatic function
- Hematocrit <35%
- Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult, such as arthritis treated with non-steroidal antiinflammatory drugs
- Treatment with chronic systemic glucocorticoid therapy
- Treatment with lithium salts
- History of alcohol or drug abuse
- Treatment with any investigational drug in the 1 month preceding
- Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
- Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6602
About this study
Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs glycemic control via effects on insulin sensitivity and insulin secretion.
Aim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor dependent mechanism.
Read the detailed description
In aim 1 subjects are randomized to cross over between an 8 day high salt and 8 day low salt diet and assessments are made.
In aim 2, subjects are randomized to a 2x2 cross over study with an 8 day low salt diet and either eplerenone 50mg or amlodipine 5mg.
- Conditions
- Metabolic Syndrome
- Being tested
- Low Salt diet plus Placebo tablet, Low Sodium diet plus Salt tablet, Epleronone, Amlodipine
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Salt diet plus Placebo tabletOther
Low Sodium diet plus Salt tabletOther
EplerononeDrug
Also called Inspra
50mg daily
AmlodipineDrug
Also called Norvasc
5mg daily
| Study group | Role | What they receive |
|---|---|---|
| Aim1-Low Sodium then High Sodium | Active comparator | Subjects will be provided with a low sodium diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.
Participants will be given low sodium diet (50mEq/d) and Placebo tablets for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Salt tables (150mEq) for 8days and assessments will be made. Receives: Other: Low Salt diet plus Placebo tablet; Other: Low Sodium diet plus Salt tablet |
| Aim 1-high salt diet then low salt diet | Active comparator | Subjects will be provided with a diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.
Participants will be given low sodium diet (50mEq/d) and Salt tables (150mEq) for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Placebo tablets for 8days and assessments will be made. Receives: Other: Low Salt diet plus Placebo tablet; Other: Low Sodium diet plus Salt tablet |
| Aim2- low salt diet and epleronone then amlodipine | Active comparator | Subjects on a low salt diet will receive Epleronone 50mg for 8 days and assessments will be made, then cross over to a low salt diet with Amlodipine 5mg for 8days and assessments will be made. Receives: Other: Low Salt diet plus Placebo tablet; Drug: Epleronone; Drug: Amlodipine |
| aim2- low salt diet and amlodipine then epleronone | Active comparator | Subjects on a low salt diet will receive Amlodipine 5mg for 8 days and assessments will be made, then cross over to a low salt diet with Epleronone 50mg for 8days and assessments will be made. Receives: Other: Low Salt diet plus Placebo tablet; Drug: Epleronone; Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Secretion
Hyperglycemic clamp- acute insulin response (AIR) during time 0-10 minutes
Measured: After 8 days of diet or drug
Insulin Sensitivity
Hyperinsulinemic clamp- glucose infusion rate during insulin administration
Measured: after 8 days of diet or medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Matt Luther, Vanderbilt University Medical Center
- Investigators
- James M Luther, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034435
- Sponsor's protocol ID
- 131139
- Status last verified
- Dec 2020
- First submitted
- 9 Jan 2014
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism
- ClinicalTrials.gov ID
- NCT02034435
- Acronym / sponsor ID
- 131139
- Conditions
- Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs glycemic control via effects on insulin sensitivity and insulin secretion.
Aim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor dependent mechanism.
Detailed description
In aim 1 subjects are randomized to cross over between an 8 day high salt and 8 day low salt diet and assessments are made.
In aim 2, subjects are randomized to a 2x2 cross over study with an 8 day low salt diet and either eplerenone 50mg or amlodipine 5mg.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aim1-Low Sodium then High Sodium | Active comparator | Other: Low Salt diet plus Placebo tablet, Other: Low Sodium diet plus Salt tabletSubjects will be provided with a low sodium diet from the Vanderbilt Clinical Research Center that will be controlled for salt content. Participants will be given low sodium diet (50mEq/d) and Placebo tablets for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Salt tables (150mEq) for 8days and assessments will be made. |
| Aim 1-high salt diet then low salt diet | Active comparator | Other: Low Salt diet plus Placebo tablet, Other: Low Sodium diet plus Salt tabletSubjects will be provided with a diet from the Vanderbilt Clinical Research Center that will be controlled for salt content. Participants will be given low sodium diet (50mEq/d) and Salt tables (150mEq) for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Placebo tablets for 8days and assessments will be made. |
| Aim2- low salt diet and epleronone then amlodipine | Active comparator | Other: Low Salt diet plus Placebo tablet, Drug: Epleronone, Drug: AmlodipineSubjects on a low salt diet will receive Epleronone 50mg for 8 days and assessments will be made, then cross over to a low salt diet with Amlodipine 5mg for 8days and assessments will be made. |
| aim2- low salt diet and amlodipine then epleronone | Active comparator | Other: Low Salt diet plus Placebo tablet, Drug: Epleronone, Drug: AmlodipineSubjects on a low salt diet will receive Amlodipine 5mg for 8 days and assessments will be made, then cross over to a low salt diet with Epleronone 50mg for 8days and assessments will be made. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ambulatory subjects, 18 to 70 years of age, inclusive
- For female subjects, the following conditions must be met:
- Metabolic Syndrome as defined by the presence of > 3 of the following:
Key exclusion criteria (22 listed)
- type 1 Diabetes
- Type II Diabetes
- Impaired renal function
- Prior allergies to medications used in the study protocol
- Screening plasma potassium >5.5 mmol/L or sodium <135 mmol/L
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 Salt diet plus Placebo tablet | Other | Aim 1-high salt diet then low salt diet, Aim1-Low Sodium then High Sodium, Aim2- low salt diet and epleronone then amlodipine, aim2- low salt diet and amlodipine then epleronone |
| Low Sodium diet plus Salt tablet | Other | Aim 1-high salt diet then low salt diet, Aim1-Low Sodium then High Sodium |
| EplerononeAlso: Inspra50mg daily | Drug | Aim2- low salt diet and epleronone then amlodipine, aim2- low salt diet and amlodipine then epleronone |
| AmlodipineAlso: Norvasc5mg daily | Drug | Aim2- low salt diet and epleronone then amlodipine, aim2- low salt diet and amlodipine then epleronone |
Primary outcome
Insulin Secretion
Time frame: After 8 days of diet or drug
Hyperglycemic clamp- acute insulin response (AIR) during time 0-10 minutes
Insulin Sensitivity
Time frame: after 8 days of diet or medication
Hyperinsulinemic clamp- glucose infusion rate during insulin administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James M Luther, MD principal investigator
Vanderbilt 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 Phase 4 study testing Low Sodium diet plus Salt tablet, Epleronone and Amlodipine in people with Metabolic Syndrome, run by Vanderbilt University Medical Center at 1 site in United States.
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 11 inclusion and 22 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 Jan 2021. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insulin Secretion (time frame: After 8 days of diet or drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2021.