Diabetes MellitusNCT00732160
Aldosterone and Glucose Homeostasis
A study testing Aldosterone infusion (A), High Sodium Diet (HS) and Low Sodium Diet (LS) in people with Diabetes Mellitus, run by Vanderbilt University at 1 site in United States.
Trial summary
Determine the effect of aldosterone on how the body handles glucose (sugar). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Aldosterone infusion (A), High Sodium Diet (HS) and Low Sodium Diet (LS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2013
- Phase
- Interventional
- 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:
- a postmenopausal status for at least 1 year, or b status-post surgical sterilization, or c 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:
- a Systolic Blood Pressure > 130 mm Hg OR Diastolic Blood Pressure > 85 mm Hg. b Glucose Intolerance (Fasting Plasma Glucose > 100 mg/dL) c Increased triglyceride level > 150mg/dL (1.7mmol/L) d Decreased levels of HDL cholesterol For males, less than 40 mg/dL For females, less than 50 mg/dL e Waist circumference For males, greater than 40 inches (102 cm) For females, greater than 35 inches (89 cm).
Who cannot join
- Previously diagnosed Type I Diabetes , or the use of anti-diabetic medication. Subjects with type II diabetes not on medication will be allowed to participate if fasting blood glucose is <200mg/dL.
- Prior allergies to medications used in the study protocol (e.g. L-arginine, potassium chloride).
- Screening plasma potassium <3.5 mmol/L or use of chronic potassium supplements for the treatment of hypokalemia
- Use of hormone replacement therapy
- If on statin therapy for hypercholesterolemia, a change in dose within the past 6 months.
- Breast-feeding
Show all 23Show fewer
- Cardiovascular disease such as prior myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
- Treatment with anticoagulants
- History of serious neurologic disease such as cerebral hemorrhage, stroke, seizure, or transient ischemic attack
- History or presence of immunological or hematological disorders
- Diagnosis of asthma requiring use of inhaled beta agonist >1 time per week
- Clinically significant gastrointestinal impairment that could interfere with drug absorption
- Impaired hepatic function [aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) >2.0 x upper limit of normal range]
- Impaired renal function [estimated glomerular filtration rate (eGFR) of <60ml/min] as determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine (Scr) is expressed in mg/dl and age in years:
- eGFR <60 ml/min
- 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 (more than 7 consecutive days in 1 month)
- Treatment with lithium salts
- History of alcohol or drug abuse
- Treatment with any investigational drug in the 1 month preceding the study
- 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
About this study
Determine the effect of aldosterone on how the body handles glucose (sugar).
Read the detailed description
Determine the effect of aldosterone on glucose metabolism in humans.
- Conditions
- Diabetes Mellitus
- Being tested
- Aldosterone infusion (A), Vehicle Infusion (V), High Sodium Diet (HS), Low Sodium Diet (LS)
- Keywords
- Glucose, Insulin
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldosterone infusion (A)Drug
Also called placebo
Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs)
Vehicle Infusion (V)Drug
Vehicle infusion for 12.5 hours
High Sodium Diet (HS)Other
160 mmol/d sodium diet for 7 days
Low Sodium Diet (LS)Other
20 mmol/d sodium diet for 9 days
| Study group | Role | What they receive |
|---|---|---|
| HS-V/A; LS-V/A | Experimental | High Sodium diet- Vehicle infusion then Aldosterone infusion Low Sodium diet- Vehicle infusion then Aldosterone infusion Receives: Drug: Aldosterone infusion (A); Drug: Vehicle Infusion (V); Other: High Sodium Diet (HS); Other: Low Sodium Diet (LS) |
| HS-A/V; LS-A/V | Experimental | High Sodium diet- Aldosterone infusion then Vehicle infusion Low Sodium diet- Aldosterone infusion then Vehicle infusion Receives: Drug: Aldosterone infusion (A); Drug: Vehicle Infusion (V); Other: High Sodium Diet (HS); Other: Low Sodium Diet (LS) |
| LS-V/A; HS-V/A | Experimental | Low Sodium diet- Vehicle infusion then Aldosterone infusion High Sodium diet- Vehicle infusion then Aldosterone infusion Receives: Drug: Aldosterone infusion (A); Drug: Vehicle Infusion (V); Other: High Sodium Diet (HS); Other: Low Sodium Diet (LS) |
| LS-A/V; HS-A/V | Experimental | Low Sodium diet- Aldosterone infusion then Vehicle infusion High Sodium diet- Aldosterone infusion then Vehicle infusion Receives: Drug: Aldosterone infusion (A); Drug: Vehicle Infusion (V); Other: High Sodium Diet (HS); Other: Low Sodium Diet (LS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Secretion
Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)
Measured: 3 hours
Secondary outcomes (1)
Insulin Sensitivity
Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2012
- Study completionDec 2013
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, James Matt Luther, Vanderbilt University
- Investigators
- James M Luther, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732160
- Sponsor's protocol ID
- 080248
- Status last verified
- Feb 2017
- First submitted
- 5 Aug 2008
- Last updated
- 6 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ramirez CE, Shuey MM, Milne GL, Gilbert K, Hui N, Yu C, Luther JM, Brown NJ. Arg287Gln variant of EPHX2 and epoxyeicosatrienoic acids are associated with insulin sensitivity in humans. Prostaglandins Other Lipid Mediat. 2014 Oct;113-115:38-44. doi: 10.1016/j.prostaglandins.2014.08.001. Epub 2014 Aug 28.
PubMed 25173047Luther JM, Byrne LM, Yu C, Wang TJ, Brown NJ. Dietary sodium restriction decreases insulin secretion without affecting insulin sensitivity in humans. J Clin Endocrinol Metab. 2014 Oct;99(10):E1895-902. doi: 10.1210/jc.2014-2122. Epub 2014 Jul 16.
PubMed 25029426Brown JM, Williams JS, Luther JM, Garg R, Garza AE, Pojoga LH, Ruan DT, Williams GH, Adler GK, Vaidya A. Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone. Hypertension. 2014 Feb;63(2):273-80. doi: 10.1161/HYPERTENSIONAHA.113.01910. Epub 2013 Nov 4.
PubMed 24191286
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aldosterone and Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT00732160
- Acronym / sponsor ID
- 080248
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 6 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the effect of aldosterone on how the body handles glucose (sugar).
Detailed description
Determine the effect of aldosterone on glucose metabolism in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HS-V/A; LS-V/A | Experimental | Drug: Aldosterone infusion (A), Drug: Vehicle Infusion (V), Other: High Sodium Diet (HS), Other: Low Sodium Diet (LS)High Sodium diet- Vehicle infusion then Aldosterone infusion Low Sodium diet- Vehicle infusion then Aldosterone infusion |
| HS-A/V; LS-A/V | Experimental | Drug: Aldosterone infusion (A), Drug: Vehicle Infusion (V), Other: High Sodium Diet (HS), Other: Low Sodium Diet (LS)High Sodium diet- Aldosterone infusion then Vehicle infusion Low Sodium diet- Aldosterone infusion then Vehicle infusion |
| LS-V/A; HS-V/A | Experimental | Drug: Aldosterone infusion (A), Drug: Vehicle Infusion (V), Other: High Sodium Diet (HS), Other: Low Sodium Diet (LS)Low Sodium diet- Vehicle infusion then Aldosterone infusion High Sodium diet- Vehicle infusion then Aldosterone infusion |
| LS-A/V; HS-A/V | Experimental | Drug: Aldosterone infusion (A), Drug: Vehicle Infusion (V), Other: High Sodium Diet (HS), Other: Low Sodium Diet (LS)Low Sodium diet- Aldosterone infusion then Vehicle infusion High Sodium diet- Aldosterone infusion then Vehicle infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ambulatory subjects, 18 to 70 years of age, inclusive
- For female subjects, the following conditions must be met:
- a postmenopausal status for at least 1 year, or b status-post surgical sterilization, or c 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:
- a Systolic Blood Pressure > 130 mm Hg OR Diastolic Blood Pressure > 85 mm Hg. b Glucose Intolerance (Fasting Plasma Glucose > 100 mg/dL) c Increased triglyceride level > 150mg/dL (1.7mmol/L) d Decreased levels of HDL cholesterol For males, less than 40 mg/dL For females, less than 50 mg/dL e Waist circumference For males, greater than 40 inches (102 cm) For females, greater than 35 inches (89 cm).
Key exclusion criteria (23 listed)
- Previously diagnosed Type I Diabetes , or the use of anti-diabetic medication. Subjects with type II diabetes not on medication will be allowed to participate if fasting blood glucose is <200mg/dL.
- Prior allergies to medications used in the study protocol (e.g. L-arginine, potassium chloride).
- Screening plasma potassium <3.5 mmol/L or use of chronic potassium supplements for the treatment of hypokalemia
- Use of hormone replacement therapy
- If on statin therapy for hypercholesterolemia, a change in dose within the past 6 months.
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 |
|---|---|---|
| Aldosterone infusion (A)Also: placeboInfusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs) | Drug | HS-A/V; LS-A/V, HS-V/A; LS-V/A, LS-A/V; HS-A/V, LS-V/A; HS-V/A |
| Vehicle Infusion (V)Vehicle infusion for 12.5 hours | Drug | HS-A/V; LS-A/V, HS-V/A; LS-V/A, LS-A/V; HS-A/V, LS-V/A; HS-V/A |
| High Sodium Diet (HS)160 mmol/d sodium diet for 7 days | Other | HS-A/V; LS-A/V, HS-V/A; LS-V/A, LS-A/V; HS-A/V, LS-V/A; HS-V/A |
| Low Sodium Diet (LS)20 mmol/d sodium diet for 9 days | Other | HS-A/V; LS-A/V, HS-V/A; LS-V/A, LS-A/V; HS-A/V, LS-V/A; HS-V/A |
Primary outcome
Insulin Secretion
Time frame: 3 hours
Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)
1 secondary outcome
Insulin Sensitivity
Time frame: 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25173047Ramirez CE, Shuey MM, Milne GL, Gilbert K, Hui N, Yu C, Luther JM, Brown NJ. Arg287Gln variant of EPHX2 and epoxyeicosatrienoic acids are associated with insulin sensitivity in humans. Prostaglandins Other Lipid Mediat. 2014 Oct;113-115:38-44. doi: 10.1016/j.prostaglandins.2014.08.001. Epub 2014 Aug 28.
- Derived from this study: PubMed 25029426Luther JM, Byrne LM, Yu C, Wang TJ, Brown NJ. Dietary sodium restriction decreases insulin secretion without affecting insulin sensitivity in humans. J Clin Endocrinol Metab. 2014 Oct;99(10):E1895-902. doi: 10.1210/jc.2014-2122. Epub 2014 Jul 16.
- Derived from this study: PubMed 24191286Brown JM, Williams JS, Luther JM, Garg R, Garza AE, Pojoga LH, Ruan DT, Williams GH, Adler GK, Vaidya A. Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone. Hypertension. 2014 Feb;63(2):273-80. doi: 10.1161/HYPERTENSIONAHA.113.01910. Epub 2013 Nov 4.
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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 study testing Aldosterone infusion (A), High Sodium Diet (HS) and Low Sodium Diet (LS) in people with Diabetes Mellitus, run by Vanderbilt University 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 5 inclusion and 23 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 6 Apr 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2017). 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: 3 hours). 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 NCT00732160, which also lists 3 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 6 Apr 2017.