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Metabolic DiseasesPhase 1NCT01103245

Aldosterone and the Metabolic Syndrome

A Phase 1 study testing Hydrochlorothiazide (HCTZ), Aliskiren 150 mg (ALI 150) and Spironolactone (SPL 25) in people with Metabolic Diseases and Diabetes Mellitus, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on glucose metabolism in humans. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Hydrochlorothiazide (HCTZ), Aliskiren 150 mg (ALI 150) and Spironolactone (SPL 25)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteUnited States
Study dates
Mar 2010to Sep 2013
Phase
Phase 1
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

  • Subjects meeting all of the following conditions will be included in the study:
  • 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.
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  • A seated or supine systolic blood pressure greater than 130/85 on three separate measurements at least 15 minutes apart
  • Metabolic Syndrome as defined by the presence of > 3 of the following:
  • Hypertension as characterized by having Systolic Blood Pressure > 140 mm Hg and Diastolic Blood Pressure > 90 mm Hg.
  • Impaired Glucose Tolerance (Fasting Plasma Glucose > 100 mg/dL)
  • Increased triglyceride level > 150mg/dL
  • Decreased levels of High-Density Lipoprotein (HDL) cholesterol
  • For males, less than 30 mg/dL
  • For females, less than 40 mg/dL
  • Waist circumference
  • For males, greater than 40 inches.
  • For females, greater than 35 inches.

Who cannot join

  • Subjects presenting with any of the following will not be included in the study:
  • Diabetes type 1 or type 2, a fasting glucose of greater than 110 mg/dL or the use of anti-diabetic medication
  • Use of hormone replacement therapy
  • Statin therapy
  • Pregnancy
  • Breast-feeding
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  • Cardiovascular disease such as prior myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure [Left Ventricular (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) >1.5 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 (ml/min/1.73m2)=175 • Scr-1.154 • age-0.203 • (1.212 if black) • (0.742 if female)
  • 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
  • Screening plasma potassium <3.2 mmol/L or use of chronic potassium supplements for the treatment of hypokalemia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Aldosterone and the Metabolic Syndrome: Renin Inhibition Versus Mineralocorticoid Receptor (MR) Antagonism

The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on glucose metabolism in humans.

Read the detailed description

The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on fasting blood glucose and glucose-stimulated insulin secretion in humans.

Being tested
Hydrochlorothiazide (HCTZ), Aliskiren 150 mg (ALI 150), Spironolactone (SPL 25), Aliskiren 300 mg (ALI 300), Spironolactone 50 mg (SPL 50)
Keywords
Glucose, Insulin
Medical subject headings
Metabolic Diseases, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydrochlorothiazide (HCTZ)Drug

    Also called HCTZ

    HCTZ 12.5mg daily

  • Aliskiren 150 mg (ALI 150)Drug

    Also called Tekturna

    Aliskiren 150mg daily

  • Spironolactone (SPL 25)Drug

    Also called Aldactone

    spironolactone 25mg daily

  • Aliskiren 300 mg (ALI 300)Drug

    Also called Tekturna

    Aliskiren 300mg daily

  • Spironolactone 50 mg (SPL 50)Drug

    Also called Aldactone

    Spironolactone 50 mg daily

Study groups in NCT01103245
Study groupRoleWhat they receive
HCTZ plus ALI 150 then ALI 300Active comparatorHydrochlorothiazide (HCTZ) 12.5mg daily for 1 month then HCTZ 12.5mg daily plus Aliskiren 150 mg (ALI 150) daily for 1 month then HCTZ 12.5mg daily plus Aliskiren 300mg ((ALI 300) for 1 month
Receives: Drug: Hydrochlorothiazide (HCTZ); Drug: Aliskiren 150 mg (ALI 150); Drug: Aliskiren 300 mg (ALI 300)
HCTZ plus ALI 150 then ALI 150 and SPL 25Active comparatorHCTZ 12.5mg daily for 1 month then HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month then HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25mg (SPL 25) daily for one month
Receives: Drug: Hydrochlorothiazide (HCTZ); Drug: Aliskiren 150 mg (ALI 150); Drug: Spironolactone (SPL 25)
HCTZ plus SPL 25 then SPL 50Active comparatorHCTZ 12.5mg daily for 1 month then HCTZ 12.5mg daily plus Spironolactone 25 mg (SPL 25) daily for 1 month then HCTZ 12.5mg daily plus Spironolactone 50 mg daily for one month
Receives: Drug: Hydrochlorothiazide (HCTZ); Drug: Spironolactone (SPL 25); Drug: Spironolactone 50 mg (SPL 50)
HCTZ plus SPL 25 then ALI 150 and SPL 25Active comparatorHCTZ 12.5mg daily for 1 month then HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month then HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month
Receives: Drug: Hydrochlorothiazide (HCTZ); Drug: Aliskiren 150 mg (ALI 150); Drug: Spironolactone (SPL 25)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma Insulin

    A Hyperglycemic clamp was performed once during each study period to assess glucose stimulated insulin secretion. Glucose is infused intravenously to maintain blood glucose near 200 mg/dL to stimulate insulin secretion. During this time plasma insulin levels were measured and the insulin response is reported as the incremental increase over the first 10 minutes of glucose administration.

    Measured: at the end of each 1 month study period ( 3 times in total)

  2. Plasma Glucose

    Fasting plasma glucose, measured during hyperglycemic clamp

    Measured: at the end of each 1 month study period ( 3 times in total)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionJul 2012
  4. Study completionSep 2013

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01103245
Sponsor's protocol ID
091072
Other IDs
09CRP2261428
Status last verified
Mar 2018
First submitted
12 Apr 2010
Last updated
5 Nov 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 25173047

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hydrochlorothiazide (HCTZ), Aliskiren 150 mg (ALI 150) and Spironolactone (SPL 25) in people with Metabolic Diseases and Diabetes Mellitus, 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 17 inclusion and 24 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 5 Nov 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 5 Nov 2018). 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?

Plasma Insulin (time frame: at the end of each 1 month study period ( 3 times in total)). 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?

On the ClinicalTrials.gov record for NCT01103245, 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 5 Nov 2018.

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